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EverFlex Post Approval Study (DURABILITY PAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01680835
First received: September 4, 2012
Last updated: November 11, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Lower Extremity Arterial Disease
Device: EverFlex™ Self-Expanding Peripheral Stent System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 113
Study Start Date: September 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680835

Contacts
Contact: Charis Sugden, BA charis.sugden@Covidien.com

Locations
United States, North Carolina
Wake Heart Research Recruiting
Raleigh, North Carolina, United States, 27610
Principal Investigator: Ravish Sachar, MD         
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Jon S Matsumura, MD University of Wisconsin, Madison
Principal Investigator: Krishna Rocha-Singh, MD Prairie Heart Institute
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01680835     History of Changes
Other Study ID Numbers: CP-1001
Study First Received: September 4, 2012
Last Updated: November 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases
Menthol
Antipruritics
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014