Peripheral Arterial Disease Clinical Trial
Official title:
Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent
Verified date | March 2014 |
Source | Cook |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics CommissionSwitzerland: Ethikkommission |
Study type | Interventional |
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.
Status | Completed |
Enrollment | 45 |
Est. completion date | September 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis - Reference vessel diameter of 4 - 9 mm - Rutherford category = 2 - Resting ankle brachial index < 0.9 Exclusion Criteria: - Prior stent in the study vessel - Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure - Lacks at least one patent runoff vessel - Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Herz-Zentrum | Bad Krozingen | |
Germany | Evangelische Krankenhaus Königin Elisabeth Herzberge | Berlin | |
Germany | Universitätsklinikum Magdeburg A.ö.R. | Magdeburg | |
Switzerland | INSELSPITAL, Universitätsspital Bern | Berne |
Lead Sponsor | Collaborator |
---|---|
Cook |
Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change in Stent Length Upon Deployment | During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment) | No |
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