Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis

NCT00530712 | Completed Results DMC

• 1 other identifier: P-2424
• Study Type: interventional
• Target: 287
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.

Conditions

Peripheral Vascular Diseases; Claudication

Keywords

SFA; Popliteal; Stent; EverFlex

Outcome Measures

Primary Outcomes (2)

• Primary Patency

  Primary stent patency, as determined by the core laboratory, was defined as PSV ratio \< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.

  1 Year

• Major Adverse Events

  Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)

  30 Days

Secondary Outcomes (12)

• Single-Stent Primary Patency

  1 Year

• Single-Stent Major Adverse Events

  30 Days

• Major Adverse Events

  1 Year

• Stent Fracture Rate

  1, 2 and 3 Years

• Number of Participants With Decline in Rutherford Clinical Category

  30 days

Study Arms (1)

PTA and Stenting with EverFlex device

EXPERIMENTAL

Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System

Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System

Interventions

PROTÉGÉ® EverFlex™ Self-Expanding Stent System DEVICE

Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.

PTA and Stenting with EverFlex device

Eligibility Criteria

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

You may qualify if:

• 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.
• Symptomatic femoral-popliteal atherosclerosis.
• Willing to comply with all follow-up evaluations at the specified times.
• Provides written informed consent prior to enrollment in the study.

You may not qualify if:

• Previously implanted stent(s) or stent graft(s) in the target vessel.
• Planned use of devices other than angioplasty balloons during procedure.
• Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
• Life expectancy of less than 12 months.
• Symptomatic femoral disease in the opposite limb.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Related Publications (1)

• Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, Scheinert D, Rocha-Singh KJ. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013 Jul;58(1):73-83.e1. doi: 10.1016/j.jvs.2012.12.066. Epub 2013 May 2.

  PMID: 23642924 RESULT

MeSH Terms

Conditions

Peripheral Vascular Diseases; Intermittent Claudication

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Cihlar
• Organization: Medtronic

stephanie.a.cihlar@medtronic.com

763-398-7932

Study Officials

• Jon Matsumura, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Krishna Rocha-Singh, MD

  Prairie Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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 14, 2007
• First Posted: September 17, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2013
• Last Updated: February 18, 2019
• Results First Posted: August 15, 2014

Record last verified: 2019-02