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EverFlex Post Approval Study (DURABILITY PAS)

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ClinicalTrials.gov Identifier: NCT01680835
Recruitment Status : Active, not recruiting
First Posted : September 7, 2012
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Lower Extremity Arterial Disease Device: EverFlex™ Self-Expanding Peripheral Stent System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2012
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680835


Locations
United States, North Carolina
Wake Heart Research
Raleigh, North Carolina, United States, 27610
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Jon S Matsumura, MD University of Wisconsin, Madison
Principal Investigator: Krishna Rocha-Singh, MD Prairie Heart Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01680835     History of Changes
Other Study ID Numbers: CP-1001
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

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