Evaluation of Efficacy and Safety of the FlexStent Femoropopliteal Self-Expanding Stent System Study -The Flexstent-Registry

Phase 4

• Conditions: I70.2; Atherosclerosis of arteries of extremities

• Registration Number: DRKS00000253
• Lead Sponsor: Park-Krankenhaus Leipzig,Zentrum für Gefäßmedizin,Klinik f. Innere Medizin I/ Angiologie, Kardiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-25
• Study Completion: 2012-02-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

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 <=150mm
6. >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

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).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>(systolic velocity ratio ¡Ý 2.5:1 suggests > 50% restenosis )