Trials / Completed
CompletedNCT01680835
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Medtronic Endovascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-01-14
- Primary completion
- 2018-10-23
- Completion
- 2019-02-04
- First posted
- 2012-09-07
- Last updated
- 2019-12-26
- Results posted
- 2019-12-26
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01680835. Inclusion in this directory is not an endorsement.