EverFlex Post Approval Study (DURABILITY PAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01680835
First received: September 4, 2012
Last updated: November 14, 2013
Last verified: November 2013

September 4, 2012
November 14, 2013
September 2012
September 2017   (final data collection date for primary outcome measure)
Primary Outcome - Composite endpoint [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01680835 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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EverFlex Post Approval Study
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Arterial Disease
  • Lower Extremity Arterial Disease
Device: EverFlex™ Self-Expanding Peripheral Stent System
Using the EverFlex™ Self-Expanding Peripheral Stent System to treat
Experimental: Study cohort
All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Intervention: Device: EverFlex™ Self-Expanding Peripheral Stent System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
169
Not Provided
September 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is willing to comply with all follow-up evaluations at the specified times.
  • Is at least 18 years old.
  • Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

  • Has any co-morbid condition that precludes endovascular treatment.
Both
18 Years and older
No
Contact: Stephanie Brucato, CCRA Stephanie.Brucato@Covidien.com
United States
 
NCT01680835
CP-1001
No
Covidien
Covidien
Not Provided
Principal Investigator: Jon S Matsumura, MD University of Wisconsin, Madison
Principal Investigator: Krishna Rocha-Singh, MD Priarie Heart Institute
Covidien
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP