I70.2
Conditions
Interventions
Group 1: procedure will be conducted up to 30 days from screening
standard medical therapy for SFA/Popliteal Artery stenting, suggested regimen:lifelong aspirin 75-100mg/d commencing at least the day before procedure, Clopidogrel loading dose of 300mg the day before
angiography of arteries with measurement of the SFA/Popliteal Artery target lesion length and normal vessel diameter immediately above and below the target lesion
Pre-stenting balloon dilatation of target lesion in all total occlusions and critical stenosis
Deployment of an appropriately sized FlexStent
Post stenting angiography assessing target lesion parameters (max and min vessel diameter, stent length), run-off vessel patency and complications
Sponsors
Park-Krankenhaus Leipzig,
Zentrum für Gefäßmedizin,
Klinik f. Innere Medizin I/ Angiologie, Kardiologie
Eligibility
Sex/Gender
All
Age
35 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Subjects, male or female, must be between the ages of 35 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. 2. 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. 3. Rutherford Classification Category 2-4 4. Single de novo lesion in the superficial femoro/popliteal artery 5. Disease segment length 70% diameter stenosis and occlusion 7. Patent ipsilateral iliac artery 8. Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle 9. Target reference vessel diameter 3.5-7.5 mm
Exclusion criteria
Exclusion criteria: 1. Target lesion previously treated with a stent or surgery. 2. Rutherford Classification Category 0,1,5 or 6. 3. Inability to tolerate antithrombotic or antiplatelet therapies. 4. Pregnancy. 5. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up. 6. Serum creatinine > 2.5 mg/dL. 7. Myocardial infarction or stroke within 90 days of enrollment. 8. Hypercoagulable state. 9. Uncontrollable hypertension. 10. Patients currently enrolled in any other clinical trial(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| evaluation of the efficacy of the FlexStent as measured by the in-stent restenosis using duplex ultrasound (DUS) following treatment, 6, and 12 month follow-up visits. (systolic velocity ratio ¡Ý 2.5:1 suggests > 50% restenosis ) | — |
Countries
Germany
Contacts
Public ContactJanine Lieschke
Provascular GmbH
Outcome results
None listed