In This SectionTexas Health Research & Education Institute
Disease or Condition
Heart / Stent
Evaluation of Safety and Efficacy of the FlexStent Femoropopliteal Self-Expanding Stent System Study
The primary objective of this study is to evaluate the safety and efficacy of the FlexStent® self-expanding stent system in patients with superficial femoral and popliteal arteries.
Subjects, male or female, must be between the ages of 35 to 80 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test within 7 days of screening.
Subjects must give written inform 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.
De Novo lesion in the Femoro-popliteal artery, including the entire extent of the superficial femoral artery and the proximal portion of the popliteal artery extending to the medial condyle 3 cm above the knee joint.
Disease segment length = 145mm.
> 70% diameter stenosis and/or occlusion based on site-determined visual angiography.
Patent ipsilateral iliac artery.
Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention.
Target reference vessel diameter 3.5-7.5mm.
Projected life expectancy of 12 months or greater.
Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements.
Patient is willing and able to provide signed informed consent.
Target vessel previously treated with a stent.
Target lesion within 1.5cm of the ostium of the SFA.
Rutherford Classification Category 0, 1, 5 or 6.
Inability to tolerate antithrombotic or antiplatlet therapies.
Pregnancy (female of child-bearing age confirmed pregnant).
Other co-morbidity risk, 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 30 days of the treatment date.
Known bleeding diathesis.
Untreated angiographically-evident thrombus in target vessel.
Patients currently enrolled in any other clinical trial.