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OptiCal COherence ToMography ABoard InformiNg AtherEctomy (COMBINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01775410
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
Avinger, Inc.

Brief Summary:
This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities.The primary disease must be located in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention.

Condition or disease Intervention/treatment Phase
Atherectomy in Diseased Lower Extremity Arteries Device: Wolverine System to perform atherectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-randomized, Multi-center Feasibility Trial of the Avinger Wolverine System, an Atherectomy Device That Provides Directional Visualization and Imaging While Removing Plaque in Diseased Lower Extremity Arteries
Study Start Date : February 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: Interventional
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
Device: Wolverine System to perform atherectomy

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 30 day follow-up ]

    Freedom from major adverse events (MAE) through 30 day follow-up:

    • Clinically driven target lesion revascularization (TLR)
    • Myocardial infarct (MI)
    • Cardiovascular related deaths
    • Unplanned, major index limb amputation
    • Device Related Events:

      • Clinically Significant Perforations
      • Clinically Significant Dissections
      • Clinically Significant Embolus
      • Pseudoaneurysm

Secondary Outcome Measures :
  1. Effectiveness [ Time Frame: During interventional procedure ]
    Technical success is defined as the percent of target lesions that has a residual diameter stenosis < 50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate

Other Outcome Measures:
  1. Secondary Safety Endpoint [ Time Frame: During interventional procedure ]
    Freedom from procedural emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator

  2. Secondary Effectiveness Endpoints [ Time Frame: At 30 days ]
    • Procedural success defined as the percent of target lesions that have residual diameter stenosis ≤30% post-Wolverine and any other adjunctive therapy.

  3. Secondary Effectiveness Endpoints [ Time Frame: At 30 days ]
    Ankle-Brachial Index at 30 days

  4. Secondary Effectiveness Endpoints [ Time Frame: At 30 days ]
    Rutherford Classification at 30 days.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Patient is a candidate for percutaneous intervention for peripheral vascular disease in the legs.
  3. Patient is willing and able to give informed consent
  4. Documented symptomatic atherosclerotic peripheral vascular disease Rutherford Classification 2-5.
  5. Reference vessel lumen proximal to target lesion >2.5 mm in diameter by visual estimation.
  6. Subject has de novo target lesion(s) with stenosis >70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Wolverine device.
  7. Target lesion length <10 cm if target lesion >70% and <99% stenosed. If target lesion a chronic total occlusion (99-100% stenosed), target lesion length <4 cm.
  8. Patient is capable of meeting requirements and be present at the follow-up clinic visits at 30 days.
  9. At least one patent tibial run-off vessel at baseline.

Exclusion Criteria:

  1. Subject is pregnant or breast feeding.
  2. Rutherford Class 0 to 1 (asymptomatic and mild claudication).
  3. Rutherford Class 6 (critical limb ischemia).
  4. Severe calcification of the target lesion.
  5. Target lesion with any type of stent or graft.
  6. Target lesion in the iliac artery.
  7. Target lesion stenosis <70%.
  8. Subjects with significant (>70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion.
  9. Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure.
  10. Planned endovascular or surgical procedure 30 days after the index procedure.
  11. Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure.
  12. Subjects with active infections whether they are being currently treated or not.
  13. Hemodialysis or GFR <30 mL/min or creatinine level >2.5mg/dL.
  14. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
  15. Evidence or history of aneurysmal target vessel within the past 2 months.
  16. History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
  17. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  18. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
  19. History of heparin-induced thrombocytopenia (HIT).
  20. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 , known coagulopathy, or INR >1.5.
  21. Any thrombolytic therapy within 2 weeks of the index procedure.
  22. Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the Wolverine into the subject.
  23. Subjects or their legal guardians who have not or will not sign the Informed Consent.
  24. Subjects who are unwilling or unable to comply with the follow-up study requirements.
  25. Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01775410

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Angiografia de Occidente
Cali, VAC, Colombia
Clinical Cardiovascular
Medellin, Colombia
Sponsors and Collaborators
Avinger, Inc.
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Responsible Party: Avinger, Inc. Identifier: NCT01775410    
Other Study ID Numbers: P 0218
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019