Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery (MOBILITY OE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01396525
First received: July 14, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.


Condition Intervention Phase
Peripheral Vascular Disease
Device: Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Non-randomized, Two Arm, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Major Adverse Event (MAE) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).


Secondary Outcome Measures:
  • Device Success [ Time Frame: Acute: from beginning of index procedure to end of procedure ] [ Designated as safety issue: No ]
    On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).

  • Technical Success [ Time Frame: Acute: from beginning of index procedure to end of procedure ] [ Designated as safety issue: No ]
    Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of < 30% by QA or as reported by the investigator.

  • Procedure Success [ Time Frame: Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner ] [ Designated as safety issue: No ]
    Procedure success is defined as technical success (device success and attainment of a final residual stenosis of < 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.

  • Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 1 month and 9 months ] [ Designated as safety issue: Yes ]
    Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Data for the 18 months, 2 and 3 year time points are not yet available as the study has not completed.

  • Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 1 month and 9 months ] [ Designated as safety issue: Yes ]
    Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).

  • Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) [ Time Frame: 1 month and 9 months ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) [ Time Frame: 1 month and 9 months ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.

  • Primary Stent Patency [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

  • Primary Stent Patency [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

  • Primary Stent Patency [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Restenosis [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Defined as ≥ 50% stenosis at follow-up.

  • Restenosis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Restenosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) [ Time Frame: 1 month and 9 months ] [ Designated as safety issue: Yes ]
    Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years

  • Kaplan-Meier Estimate of Freedom From Embolic Events [ Time Frame: 1 month and 9 months ] [ Designated as safety issue: Yes ]
    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years

  • Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) [ Time Frame: 1 month and 9 months ] [ Designated as safety issue: Yes ]
    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years

  • Rutherford Becker Clinical Category for the Treated Limb(s) [ Time Frame: Pre-Procedure ] [ Designated as safety issue: No ]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

    Category Clinical Description 0 Asymptomatic, no hemodynamically significant occlusive disease

    1. Mild claudication
    2. Moderate claudication
    3. Severe claudication
    4. Ischemic rest pain
    5. Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia
    6. Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

  • Rutherford Becker Clinical Category for the Treated Limb(s) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

    Category Clinical Description 0 Asymptomatic, no hemodynamically significant occlusive disease

    1. Mild claudication
    2. Moderate claudication
    3. Severe claudication
    4. Ischemic rest pain
    5. Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia
    6. Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

  • Rutherford Becker Clinical Category for the Treated Limb(s) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

    Category Clinical Description 0 Asymptomatic, no hemodynamically significant occlusive disease

    1. Mild claudication
    2. Moderate claudication
    3. Severe claudication
    4. Ischemic rest pain
    5. Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia
    6. Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

  • Rutherford Becker Clinical Category for the Treated Limb(s) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rutherford Becker Clinical Category for the Treated Limb(s) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Changes in Quality of Life Measures: Physical Component Summary [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]

    This measure indicates the absolute change between two timepoints represented by the mean.

    SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.


  • Changes in Quality of Life Measures: Physical Component Summary [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]

    This measure indicates the absolute change between two timepoints represented by the mean.

    SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.


  • Changes in Quality of Life Measures: Mental Component Summary [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]

    This measure indicates the absolute change between two timepoints represented by the mean.

    SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.


  • Changes in Quality of Life Measures: Mental Component Summary [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]

    This measure indicates the absolute change between two timepoints represented by the mean.

    SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.


  • Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: Pre-procedure ] [ Designated as safety issue: No ]
    The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

  • Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: Post-Procedure ] [ Designated as safety issue: No ]
    The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

  • Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

  • Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

  • Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) [ Time Frame: 1 month and 9 months ] [ Designated as safety issue: Yes ]
    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years

  • Kaplan-Meier Estimate of Freedom From Death (All Cause) [ Time Frame: 1 month and 9 months ] [ Designated as safety issue: Yes ]
    Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years

  • Kaplan-Meier Estimate of Freedom From Death (All Cause) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Death (All Cause) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Death (All Cause) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Embolic Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Embolic Events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Walking Impairment Questionaire Scores [ Time Frame: Pre-procedure ] [ Designated as safety issue: No ]
    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

  • Walking Impairment Questionaire Scores [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

  • Walking Impairment Questionaire Scores [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

  • Walking Impairment Questionaire Scores [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Walking Impairment Questionaire Scores [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) [ Time Frame: Between baseline and 9 months ] [ Designated as safety issue: No ]
    Subjects in this analysis include those who had Rutherford-Becker scale completed at both baseline and within the 9 month time window. This measure provides the percentage of limbs with change between those time points.

  • Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
    Subjects in this analysis include those who had Rutherford-Becker scale completed at both baseline and within the 9 month time window. This measure provides the percentage of limbs with change between those time points.

  • Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) [ Time Frame: Baseline and 3 years ] [ Designated as safety issue: No ]
    Subjects in this analysis include those who had Rutherford-Becker scale completed at both baseline and within the 9 month time window. This measure provides the percentage of limbs with change between those time points.

  • Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

  • Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

  • Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: Between baseline and Post-procedure ] [ Designated as safety issue: No ]
    The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.

  • Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: Between Baseline and 1 month ] [ Designated as safety issue: No ]
    The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.

  • Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: Between baseline and 9 months ] [ Designated as safety issue: No ]
    The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.

  • Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

  • Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.


Enrollment: 153
Study Start Date: March 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omnilink Elite™ Peripheral Balloon-Expandable Stent System Device: Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Clinical Inclusion Criteria:

  1. Subject must be at least 18 and < 90 years of age.
  2. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form.
  3. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
  4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).
  5. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months.

Angiographic Inclusion Criteria

  1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side).
  2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion)
  3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis
  4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro)
  5. Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm
  6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro)
  7. On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.
  8. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite).
  9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite).

Clinical Exclusion Criteria

  1. Subject is unable to walk.
  2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery.
  3. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver).
  4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.
  5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s).
  6. Subject has elevated serum creatinine > 2.0 mg/dl.
  7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl).
  8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days.
  9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk.
  10. Subject has unstable angina defined as rest angina with ECG changes.
  11. Subject has a groin infection, or an acute systemic infection that is currently under treatment.
  12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
  13. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure.
  14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years).
  15. Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints.
  16. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits.
  17. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
  18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®).
  19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
  20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.
  21. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
  22. Requirement of general anesthesia or spinal block for the procedure.
  23. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.
  24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion.
  25. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary.
  26. Target lesion is in an iliac artery that has been previously stented.

Angiographic Exclusion Criteria

  1. Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion.
  2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion
  3. Target lesion is within or adjacent to an aneurysm.
  4. Lesion is located within or beyond a vessel that contains a bypass graft.
  5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.
  6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3cm.
  7. Lesion extends beyond the inguinal ligament.
  8. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies.
  9. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure.
  10. On the treatment side(s), subject is without patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.
  11. Requirement for > 1 stent to treat full length of lesion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396525

Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Tony S. Das, MD, FACC Presbyterian Heart Institute, Dallas, TX
Principal Investigator: Manish Mehta, MD, MPH, FACS Albany Medical Center, Albany, NY.
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01396525     History of Changes
Other Study ID Numbers: 08-107 Omnilink Elite Arm (OE), 08-107 AP, NCT00844532
Study First Received: July 14, 2011
Results First Received: August 29, 2012
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Atherosclerosis
Peripheral artery disease
Peripheral vascular disease
PAD
Claudication
Peripheral Arterial Occlusive Disease
Stent
PAOD
PVD

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 01, 2014