EverFlex Post Approval Study

NCT01680835 | Completed Results

• 1 other identifier: CP-1001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Peripheral Arterial Disease; Lower Extremity Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Secondary Outcome - Freedom From Stent Fracture

  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

  1 and 2 years

• Secondary Outcome - Freedom From 36-month Amputation

  3 Years

• Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization

  3 Years

• Secondary Outcome - Number of Participants Free From Acute Death

  30 days

Study Arms (1)

Study cohort

EXPERIMENTAL

All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.

Device: EverFlex™ Self-Expanding Peripheral Stent System

Interventions

EverFlex™ Self-Expanding Peripheral Stent System DEVICE

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.

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Has a Rutherford Clinical Category Score of 2, 3 or 4.
• Is willing to comply with all follow-up evaluations at the specified times.
• Is ≥ to18 years old.
• Provides written informed consent prior to enrollment in the study.
• 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.
• Evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s).
• Target lesion(s) total length is ≥ 4 cm and ≤ 18 cm.
• Target vessel diameter is ≥ 4.5 mm and ≤ 7.5 mm.
• 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.

You may not qualify if:

• Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
• 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.
• Has known hypersensitivity to nickel-titanium.
• Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses blood transfusion.
• Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures.
• Has life expectancy of less than 1 year.
• Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices during procedure.
• Has previously been enrolled in the DURABILITY PAS study.
• 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.
• Has any planned surgical intervention or endovascular procedure 14 days before or 30 days after the index procedure.
• 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.
• Has any co-morbid condition that precludes endovascular treatment.
• Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel lumen distal to lesion(s).
• Presence of significant (\> 50% stenosis or occlusion) ipsilateral common femoral stenosis.
• Aneurysmal target vessel.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (23)

St. Luke's Medical Center

Phoenix, Arizona, 85006, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95819, United States

Location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

First Coast Cardiovascular Institute, P.A.

Jacksonville, Florida, 32216, United States

Location

Augusta Vascular Center

Augusta, Georgia, 30901, United States

Location

DuPage Medical Group

Downers Grove, Illinois, 60515, United States

Location

Rockford Cardiovascular Associates

Rockford, Illinois, 61107, United States

Location

Central Iowa Hospital Corporation

Des Moines, Iowa, 50266, United States

Location

Cardiovascular Solutions, LLC

Shreveport, Louisiana, 71103, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Mercy Hospital/Metropolitan Cardiology Consultants

Coon Rapids, Minnesota, 55433, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Wake Heart Research

Raleigh, North Carolina, 27607, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, 19010, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19147, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Black Hills Cardiovascular Research

Rapid City, South Dakota, 57701, United States

Location

Sanford Research

Sioux Falls, South Dakota, 57117, United States

Location

Premier Surgical Associates

Knoxville, Tennessee, 37909, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Bellin Memorial Hospital

Green Bay, Wisconsin, 54301, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Jennifer Seamans, M.S., Clinical Research Program Manager
• Organization: Medtronic

jennifer.l.seamans@medtronic.com

763-398-7455

Study Officials

• Jon S Matsumura, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Krishna Rocha-Singh, MD

  Prairie Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: January 14, 2013
• Primary Completion: October 23, 2018
• Study Completion: February 4, 2019
• Last Updated: December 26, 2019
• Results First Posted: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)