The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00814970
First received: December 23, 2008
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).


Condition Intervention
Peripheral Vascular Disease
Device: Complete SE Vascular Stent System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Complete® SE SFA Study: The Medtronic Complete Self-Expanding SFA Stent System for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Major Adverse Event (MAE) Rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.

  • Primary Patency Rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).


Secondary Outcome Measures:
  • Major Adverse Event (MAE) Rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.

  • Major Adverse Event (MAE) Rate [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.

  • Device Success [ Time Frame: At time of deployment ] [ Designated as safety issue: Yes ]
    The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.

  • Lesion Success [ Time Frame: At time of deployment ] [ Designated as safety issue: Yes ]
    The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.

  • Procedure Success [ Time Frame: At time of hospital discharge ] [ Designated as safety issue: Yes ]
    The ourcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.

  • Assisted Primary Patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Defined as vessel patency resulting from a procedure performed in the treated segment.

  • Secondary Patency Rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Defined as vessel patency resulting from any procedure that restores patency.

  • Change in Quality of Life - Improvment in Rutherford Class by >= 1 Category [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Improvement in Rutherford class by ≥ 1 category at 12 months from pre-procedure according to the Rutherford Scale Classification.

  • Change in Quality of Life - Increase in ABI or TBI >= 0.15 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure.

  • Change in Quality of Life - Decrease in Rutherford Class >= 1 Category [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification.

  • Stent Integrity [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.

  • Clinically-driven TLR Rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

    Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes > within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one

    > category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15


  • Major Adverse Event (MAE) Rate [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.

  • Major Adverse Event (MAE) Rate [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
    Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.

  • Stent Integrity [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.

  • Strent Integrity [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
    Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.


Enrollment: 196
Study Start Date: November 2008
Study Completion Date: December 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Complete SE Vascular Stent System
COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.
Device: Complete SE Vascular Stent System
Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).

Detailed Description:

The Complete Self-Expanding (SE) SFA Stent is designed to be a permanent implant. It is cut from a nickel titanium alloy (Nitinol) tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. Each segment consists of two struts and a crown (Figure 1). It is designed to produce optimal luminal diameter and increased scaffolding, and to maintain luminal patency.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Rutherford 2-4, with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and ABI/TBI <0.90/0.80.
  2. Target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur;
  3. Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate);
  4. Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate);
  5. Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel <50% stenosed;
  6. Life expectancy >12 months.

    Exclusion Criteria:

  7. Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
  8. Any condition that precludes safe access with PTA devices, such as: excessive peripheral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified;
  9. Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
  10. Previous treatment to the target lesion within the 3 months prior to enrollment; previous femoropopliteal bypass in target vessel; previous stenting of the target lesion;
  11. Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion;
  12. Target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure);
  13. History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
  14. Known impaired renal function, defined as creatinine >2.5 mg/dl;
  15. Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3;
  16. Known WBC of <3,000 cells/mm3;
  17. Participation in another investigational device or drug study and has not completed the primary endpoint(s) or which clinically interferes with the Complete SE SFA Study endpoints, or previously enrolled in the Complete SE SFA Study.
  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: NCT00814970

Locations
United States, California
Washington Hospital
Fremont, California, United States, 94538
United States, Florida
N. Florida Regional Medical Center
Gainesville, Florida, United States, 32605
Munroe Regional Medical Center
Ocala, Florida, United States, 34478
United States, South Carolina
AnMed Health
Anderson, South Carolina, United States, 29621
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: John Laird, MD University of California, Davis
Principal Investigator: Dierk Scheinert, PD Park-Krankenhaus Leipzig-Sudost GmbH
  More Information

No publications provided by Medtronic Endovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00814970     History of Changes
Other Study ID Numbers: IP105, IDE G080143
Study First Received: December 23, 2008
Results First Received: April 22, 2014
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
PAD
peripheral arterial disease
stent
SFA
PPA

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 25, 2014