EverFlex Post Approval Study (DURABILITY PAS)
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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. |
ClinicalTrials.gov Identifier: NCT01680835 |
Recruitment Status
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Active, not recruiting
First Posted
: September 7, 2012
Last Update Posted
: February 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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Peripheral Arterial Disease Lower Extremity Arterial Disease | Device: EverFlex™ Self-Expanding Peripheral Stent System | Not Applicable |
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 |

Arm | Intervention/treatment |
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Experimental: Study cohort
All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.
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Device: EverFlex™ Self-Expanding Peripheral Stent System
Using the EverFlex™ Self-Expanding Peripheral Stent System to treat
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, North Carolina | |
Wake Heart Research | |
Raleigh, North Carolina, United States, 27610 |
Principal Investigator: | Jon S Matsumura, MD | University of Wisconsin, Madison | |
Principal Investigator: | Krishna Rocha-Singh, MD | Prairie Heart Institute |
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 |