Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System

Completed · Not applicable

Conditions studied: Peripheral Artery Disease, Peripheral Vascular Disease, Vascular Disease, Cardiovascular Diseases, PAD

In brief

This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal. The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.

Key facts

Study ID

NCT01355406

Run by

Cordis US Corp.

People needed

257

Starts

2011-09-16

Expected to finish

2018-04-10

Last updated by the study team

2018-06-29

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects must meet the following criteria:
• Subjects, male or female, must be at least 35 years of age 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 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.
• Rutherford Classification Category 2-4
• De novo lesion in the Femoropopliteal 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 ≤ 180 mm
• >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 3.5-7.5 mm.
• 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

You may not qualify if…

• Any subject meeting any of the following criteria will be excluded from the study.
• Target vessel previously treated with a stent
• Target lesion within 1.5 cm of the ostium of the SFA
• Rutherford Classification Category 0,1,5 or 6
• Inability to tolerate antithrombotic or antiplatelet therapies
• Pregnancy (female of child-bearing age confirmed pregnant)
• Other comorbidity risks 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 treatment date
• Known hypercoagulable state
• Known bleeding diathesis
• Untreated angiographically-evident thrombus in target vessel
• Patients currently enrolled in any other clinical trial

Where it is running

• Abrazo Health Care Clinical & Trans. Research — Phoenix, Arizona, United States
• Yuma Regional Medical Center — Yuma, Arizona, United States
• El Camino Hospital — Mountain View, California, United States
• Yale University/New Haven Hospital — New Haven, Connecticut, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• Florida Research Network — Gainesville, Florida, United States
• Memorial Hospital — Jacksonville, Florida, United States
• Baptist Cardiac & Vascular Institute — Miami, Florida, United States
• Mount Sinai Miami Medical Center — Miami Beach, Florida, United States
• Florida Hospital Pepin Heart Institute — Tampa, Florida, United States
• University Hospital — Augusta, Georgia, United States
• St. John's Hospital — Springfield, Illinois, United States
• Midwest Cardiovascular Research Foundation / Trinity Medical Center — Davenport, Iowa, United States
• Healient Physician Group — Overland Park, Kansas, United States
• Lafayette General Medical Center — Lafayette, Louisiana, United States
• Christus St. Patrick Hospital — Lake Charles, Louisiana, United States
• Glenwood Regional Medical Center — West Monroe, Louisiana, United States
• Washington Adventist Hospital / Center for Cardiac & Vascular Research — Takoma Park, Maryland, United States
• Deborah Heart — Browns Mills, New Jersey, United States
• Cardiovascular Associates of the Delaware Valley — Haddon Heights, New Jersey, United States
• Our Lady of Lourdes Medical Center — Haddon Heights, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• Gotham Cardiovascular Research, PC — New York, New York, United States
• Columbia University Medical Center, Center for Interventional Vascular Therapy — New York, New York, United States
• CarolinaEast Health Center — New Bern, North Carolina, United States

Full record on ClinicalTrials.gov

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