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

Not Applicable

Completed

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

Interventions: Device: FlexStent® Femoropopliteal Self Expanding Stent System

Registration Number: NCT01355406

Lead Sponsor: Cordis Corporation

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 257

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAD	FlexStent® Femoropopliteal Self Expanding Stent System	This is a prospective single-arm multi-center clinical trial designed to evaluate the safety and efficacy of the Flexible Stenting Solutions Flext Stent® Femoropopliteal stenting system in subjects with lower limb peripheral arterial desease (PAD). Subjects targeted for enrollment must have a single de-novo lesion located in the superficial femoral artery and/or proximal popliteal artery with at \> 70% stenosis. Subjects must meet all enrollment criteria and provide written informed consent prior to participation in the study.

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is vessel patency at 12 months.	12 Months	The primary efficacy endpoint is vessel patency at 12 months. Vessel patency is defined as freedom from a greater than 50% restenosis in the stented segment as determined by the DUS peak systolic velocity ratio (PSVR) comparing data within the treated segment to the proximal normal arterial segment and freedom from clinically-driven TLR within the stented segment within 1 year of the procedure.
The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days.	30 Days	The primary safety endpoint is defined as freedom from all cause death, index limb amputation and target lesion revascularization (TLR) through 30 days. The proportion of patients remaining free from this composite endpoint will be compared to a safety performance goal for bare nitinol stents.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (38): El Camino Hospital
🇺🇸
Mountain View, California, United States
University Hospital
🇺🇸
Augusta, Georgia, United States
Allegheny General Hospital/Forbes Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Glenwood Regional Medical Center
🇺🇸
West Monroe, Louisiana, United States
Rex Healthcare
🇺🇸
Raleigh, North Carolina, United States
St. John's Hospital
🇺🇸
Springfield, Illinois, United States
Holy Spirit Hospital
🇺🇸
Camp Hill, Pennsylvania, United States
Deborah Heart
🇺🇸
Browns Mills, New Jersey, United States
Riverside Methodist Hospital / MidWest Cardiology Research Foundation
🇺🇸
Columbus, Ohio, United States
Lafayette General Medical Center
🇺🇸
Lafayette, Louisiana, United States
CarolinaEast Health Center
🇺🇸
New Bern, North Carolina, United States
Sanford Research/USD/Sanford Clinic
🇺🇸
Fargo, North Dakota, United States
Midwest Cardiovascular Research Foundation / Trinity Medical Center
🇺🇸
Davenport, Iowa, United States
Christus St. Patrick Hospital
🇺🇸
Lake Charles, Louisiana, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸
Haddon Heights, New Jersey, United States
Gotham Cardiovascular Research, PC
🇺🇸
New York, New York, United States
Holy Name Medical Center
🇺🇸
Teaneck, New Jersey, United States
Healient Physician Group
🇺🇸
Overland Park, Kansas, United States
A.Z. Sint-Blasius Hospital / Flanders Medical Research Program
🇧🇪
Dendermonde, Belgium
Our Lady of Lourdes Medical Center
🇺🇸
Haddon Heights, New Jersey, United States
Miriam Hospital
🇺🇸
Providence, Rhode Island, United States
Columbia University Medical Center, Center for Interventional Vascular Therapy
🇺🇸
New York, New York, United States
Aurora St. Luke's Medical Center / Aurora Medical Group
🇺🇸
Milwaukee, Wisconsin, United States
Cardiovascular Research Institute of Dallas
🇺🇸
Dallas, Texas, United States
Providence Sacred Heart Medical Center / Providence Spokane Cardiology
🇺🇸
Spokane, Washington, United States
Wisconsin Heart Hospital
🇺🇸
Milwaukee, Wisconsin, United States
Sentara Vascular Specialists
🇺🇸
Norfolk, Virginia, United States
Imelda Hospital / Flanders Medical Research Program
🇧🇪
Bonheiden, Belgium
Washington Adventist Hospital / Center for Cardiac & Vascular Research
🇺🇸
Takoma Park, Maryland, United States
Yuma Regional Medical Center
🇺🇸
Yuma, Arizona, United States
Abrazo Health Care Clinical & Trans. Research
🇺🇸
Phoenix, Arizona, 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
Mount Sinai Miami Medical Center
🇺🇸
Miami Beach, Florida, United States
Baptist Cardiac & Vascular Institute
🇺🇸
Miami, Florida, United States
Florida Hospital Pepin Heart Institute
🇺🇸
Tampa, Florida, United States