EverFlex Post Approval Study (DURABILITY PAS)

The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the EverfLex NitInol STent System Post Approval Study

This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Lower Extremity Arterial Disease
• Intervention / Treatment: Device: EverFlex™ Self-Expanding Peripheral Stent System

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • St. Luke's Medical Center
  • California
    • Modesto, California, United States, 95355
      • Memorial Medical Center
    • Sacramento, California, United States, 95819
      • Sutter Memorial Hospital
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health Services
  • Florida
    • Jacksonville, Florida, United States, 32216
      • First Coast Cardiovascular Institute, P.A.
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Augusta Vascular Center
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • DuPage Medical Group
    • Rockford, Illinois, United States, 61107
      • Rockford CardioVascular Associates
  • Iowa
    • Des Moines, Iowa, United States, 50266
      • Central Iowa Hospital Corporation
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Cardiovascular Solutions, LLC
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital/Metropolitan Cardiology Consultants
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Wake Heart Research
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Lankenau Institute for Medical Research
    • Philadelphia, Pennsylvania, United States, 19147
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Cardiovascular Research
    • Sioux Falls, South Dakota, United States, 57117
      • Sanford Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Premier Surgical Associates
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Bellin Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

General Inclusion Criteria

1. Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts), or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries suitable for primary stenting.
2. Has a Rutherford Clinical Category Score of 2, 3 or 4.
3. Is willing to comply with all follow-up evaluations at the specified times.
4. Is ≥ to18 years old.
5. Provides written informed consent prior to enrollment in the study.

Angiographic Inclusion Criteria Subjects must meet all of the following angiographic inclusion criteria. The implanting physician bases all angiographic inclusion criteria on visual determination at the time of the procedure.

1. Target lesion(s) located within the native SFA/proximal popliteal: distal point at least 3 cm above the cortical margin of the femur and proximal point at least 1 cm below the origin of the profunda femoralis measured by straight posteroanterior (PA) view for distal lesions, ipsilateral oblique view for proximal lesions.
2. Evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s).
3. Target lesion(s) total length is ≥ 4 cm and ≤ 18 cm.
4. Target vessel diameter is ≥ 4.5 mm and ≤ 7.5 mm.
5. There is evidence of at least one runoff vessel to the ankle/foot of the limb to be treated that does not also require treatment for significant (> 50% stenosis or occlusion) stenosis during the index procedure.

General Exclusion Criteria

1. Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
2. Has a contraindication or known allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, contrast media or any other drug used in study according to the protocol.
3. Has known hypersensitivity to nickel-titanium.
4. Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses blood transfusion.
5. Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures.
6. Has life expectancy of less than 1 year.
7. Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices during procedure.
8. Has previously been enrolled in the DURABILITY PAS study.
9. Has received endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure.
10. Has any planned surgical intervention or endovascular procedure 14 days before or 30 days after the index procedure.
11. Is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
12. Has any co-morbid condition that precludes endovascular treatment.

Angiographic Exclusion Criteria The subject must not meet any of the following angiographic exclusion criteria. The implanting physician bases all angiographic exclusion criteria on visual determination at the time of the procedure.

1. Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel lumen distal to lesion(s).
2. Presence of significant (> 50% stenosis or occlusion) ipsilateral common femoral stenosis.
3. Aneurysmal target vessel.
4. Presence of an acute intraluminal thrombus at the proposed lesion site.
5. Perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to start of PTA procedure.
6. Focal popliteal disease in the absence of femoral disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study cohort; All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.	Device: EverFlex™ Self-Expanding Peripheral Stent System; Using the EverFlex™ Self-Expanding Peripheral Stent System to treat atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization	Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.	3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome - Freedom From Stent Fracture	Determined by x-ray at 1, 2 and 3 years using the following classifications: Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration AND the following categories: Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine	1, 2 and 3 years
Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years	Defined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure.	1 and 2 years
Secondary Outcome - Freedom From 36-month Amputation	Defined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure.	3 Years
Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization	Defined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure.	3 Years
Secondary Outcome - Number of Participants Free From Acute Death	Defined as the absence of all-cause mortality occurring within 30 days of the procedure.	30 days
Secondary Outcome - Number of Successfully Implanted Stents	Defined as the ability to deploy the stent as intended at the treatment site.	At procedure
Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year	Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.	1 Year
Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year	Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.	1 Year
Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year	Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes	1 Year
Secondary Outcome - Number of Adverse Events	Number of Adverse Events in the study through 3 Years.	3 Years

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Jon S Matsumura, MD, University of Wisconsin, Madison; Principal Investigator: Krishna Rocha-Singh, MD, Prairie Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2013
• Primary Completion (Actual): October 23, 2018
• Study Completion (Actual): February 4, 2019

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CP-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No