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 :
Completed
First Posted : September 7, 2012
Results First Posted : December 26, 2019
Last Update Posted : December 26, 2019
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Sponsor:
Medtronic Endovascular
Information provided by (Responsible Party):
Medtronic Endovascular
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 4, 2012 | ||||||
First Posted Date ICMJE | September 7, 2012 | ||||||
Results First Submitted Date ICMJE | October 23, 2019 | ||||||
Results First Posted Date ICMJE | December 26, 2019 | ||||||
Last Update Posted Date | December 26, 2019 | ||||||
Actual Study Start Date ICMJE | January 14, 2013 | ||||||
Actual Primary Completion Date | October 23, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization [ Time Frame: 3 Years ] 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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Original Primary Outcome Measures ICMJE |
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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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | EverFlex Post Approval Study | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: EverFlex™ Self-Expanding Peripheral Stent System
Using the EverFlex™ Self-Expanding Peripheral Stent System to treat atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.
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Study Arms ICMJE | 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
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
108 | ||||||
Original Estimated Enrollment ICMJE |
169 | ||||||
Actual Study Completion Date ICMJE | February 4, 2019 | ||||||
Actual Primary Completion Date | October 23, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | General Inclusion Criteria
Angiographic Inclusion Criteria Subjects must meet all of the following angiographic inclusion criteria. The implanting physician bases all angiographic inclusion criteria on visual determination at the time of the procedure.
General Exclusion Criteria
Angiographic Exclusion Criteria The subject must not meet any of the following angiographic exclusion criteria. The implanting physician bases all angiographic exclusion criteria on visual determination at the time of the procedure.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01680835 | ||||||
Other Study ID Numbers ICMJE | CP-1001 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Medtronic Endovascular | ||||||
Study Sponsor ICMJE | Medtronic Endovascular | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Medtronic Endovascular | ||||||
Verification Date | December 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |