Trials / Completed
CompletedNCT00530712
Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis
The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 287 (actual)
- Sponsor
- Medtronic Endovascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PROTÉGÉ® EverFlex™ Self-Expanding Stent System | Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery. |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2012-03-01
- Completion
- 2013-07-01
- First posted
- 2007-09-17
- Last updated
- 2019-02-18
- Results posted
- 2014-08-15
Source: ClinicalTrials.gov record NCT00530712. Inclusion in this directory is not an endorsement.