DRKS00004546
Completed
未知
Randomized Evaluation of the Zilver® PTX® Stent vs Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery - REAL PTX
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- I70.2
- Sponsor
- Provascular GmbH
- Enrollment
- 150
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject age \= 18
- •2\. Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
- •3\. Subject understands the duration of the study, agrees to attend follow\-up visits, and agrees to complete the required testing.
- •4\. Rutherford category 2\-5\.
- •5\. Subject has a de novo or restenotic lesion with \= 70% stenosis documented angiographically and no prior stent in the target lesion.
- •6\.Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
- •7\. A single target lesion (stenotic areas separated by more than 3 cm with \= 30% stenosis might, at the decision of the investigator, be considered as 2 lesions).
- •8\. Reference vessel diameter (RVD) \= 4 mm and \= 6\.5 mm by visual assessment.
- •9\. Patency of at least one (1\) infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
- •10\. A guidewire has successfully traversed the target treatment segment.
Exclusion Criteria
- •Clinical exclusion criteria
- •1\. Inability to obtain informed consent.
- •2\. Life expectancy \< 12 months.
- •3\. Pregnancy, suspected pregnancy, or breastfeeding during study period (patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment).
- •4\. Presence of one or more of the following co\-morbid factors: hemodialysis dependence, renal insufficiency with a serum creatinine \= 2\.5 mg/dl, cerebrovascular accident (CVA) within 1 month of procedure or any CVA resulting in unresolved walking impairment, and/or myocardial infarction (MI) within 1 month of procedure.
- •5\. Any evidence of hemodynamic instability prior to procedure/randomization.
- •6\. Coagulopathy or clotting disorders.
- •7\. Present or suspected systemic infection or osteomyelitis affecting target limb.
- •8\. Contraindication to contrast media or any study\-required medication (antiplatelets, anticoagulants, thrombolytics, etc).
- •9\. Hypersensitivity to nitinol and/or paclitaxel.
Outcomes
Primary Outcomes
Not specified
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