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EverFlex Post Approval Study (DURABILITY PAS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680835
First Posted: September 7, 2012
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Endovascular
September 4, 2012
September 7, 2012
March 16, 2017
September 2012
April 2019   (Final data collection date for primary outcome measure)
Primary Outcome - Composite endpoint [ Time Frame: 36 months ]
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
Not Provided
 
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Active, not recruiting
108
April 2019
April 2019   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01680835
CP-1001
No
Not Provided
Not Provided
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: Jon S Matsumura, MD University of Wisconsin, Madison
Principal Investigator: Krishna Rocha-Singh, MD Prairie Heart Institute
Medtronic Endovascular
March 2017

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