Superficial Femoral Artery Stenosis Clinical Trial
— SUMMITOfficial title:
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry
Verified date | April 2014 |
Source | Provascular GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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). |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Herz-Zentrum | Bad Krozingen | |
Germany | Weisseritztal-Kliniken | Freital | |
Germany | Park-Krankenhaus | Leipzig | |
Germany | Medinos Kliniken | Sonneberg |
Lead Sponsor | Collaborator |
---|---|
Provascular GmbH | Boston Scientific Corporation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS) | Binary restenosis is defined as a peak systolic velocity ratio (PSVR) =2.5:1. | at 6 months after procedure | No |
Primary | efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS) | Binary restenosis is defined as a peak systolic velocity ratio (PSVR) =2.5:1. | at 12 months after procedure | No |
Secondary | Technical Success | defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%. | after stent placement intra-procedural via angiographic images (day 1) | Yes |
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