Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent

About this trial

Last updated 12 years ago

Study ID

Prov 01 - 2011

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 85 Years

All Sexes

Trial Timing

Ended 14 years ago

What is this trial about?

The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in patients with superficial femoral/ popliteal artery disease. 100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time the stent will be placed, and follow-up visits at 6 and 12 months. Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will be efficacious in patients with Superficial Femoro/Popliteal Artery disease.

What are the participation requirements?

Inclusion Criteria

* Subjects, male or female, must be between the ages of 18 to 85 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening.

* Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.

* Rutherford Classification Category 2-4

* Single de novo lesion in the superficial femoro/popliteal artery

* Disease segment length ≤150mm

* >70% diameter stenosis and occlusion

* Patent ipsilateral iliac artery

* Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle

* Target reference vessel diameter 3.5-7.5 mm

Exclusion Criteria

* Target lesion previously treated with a stent or surgery.

* Rutherford Classification Category 0, 1, 5 or 6.

* Inability to tolerate antithrombotic or antiplatelet therapies.

* Pregnancy.

* Other co morbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.

* Serum creatinine > 2.5 mg/dL.

* Myocardial infarction or stroke within 90 days of enrollment.

* Hypercoagulable state.

* Uncontrollable hypertension.

* Patients currently enrolled in any other clinical trial(s).