Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
OPEN
1 other identifier
interventional
257
2 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 18, 2011
CompletedStudy Start
First participant enrolled
September 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2018
CompletedJune 29, 2018
June 1, 2018
4.3 years
May 16, 2011
June 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 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.
30 Days
The primary efficacy endpoint is vessel patency at 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.
12 Months
Study Arms (1)
PAD
OTHERThis 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.
Interventions
Transcatheter over guidewire placement of an intravascular stent(s)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cordis US Corp.lead
- Massachusetts General Hospitalcollaborator
- Prairie Education and Research Cooperativecollaborator
Study Sites (38)
Abrazo Health Care Clinical & Trans. Research
Phoenix, Arizona, 85006, United States
Yuma Regional Medical Center
Yuma, Arizona, 85364, United States
El Camino Hospital
Mountain View, California, 94040, United States
Yale University/New Haven Hospital
New Haven, Connecticut, 06510, United States
Manatee Memorial Hospital
Bradenton, Florida, 34205, United States
Florida Research Network
Gainesville, Florida, 32605, United States
Memorial Hospital
Jacksonville, Florida, 32256, United States
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176, United States
Mount Sinai Miami Medical Center
Miami Beach, Florida, 33140, United States
Florida Hospital Pepin Heart Institute
Tampa, Florida, 33613, United States
University Hospital
Augusta, Georgia, 30901, United States
St. John's Hospital
Springfield, Illinois, 62769, United States
Midwest Cardiovascular Research Foundation / Trinity Medical Center
Davenport, Iowa, 52803, United States
Healient Physician Group
Overland Park, Kansas, 66211, United States
Lafayette General Medical Center
Lafayette, Louisiana, 70506, United States
Christus St. Patrick Hospital
Lake Charles, Louisiana, 70601, United States
Glenwood Regional Medical Center
West Monroe, Louisiana, 71291, United States
Washington Adventist Hospital / Center for Cardiac & Vascular Research
Takoma Park, Maryland, 20912, United States
Deborah Heart
Browns Mills, New Jersey, 08015, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08103, United States
Our Lady of Lourdes Medical Center
Haddon Heights, New Jersey, 08103, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
Gotham Cardiovascular Research, PC
New York, New York, 10001, United States
Columbia University Medical Center, Center for Interventional Vascular Therapy
New York, New York, 10032, United States
CarolinaEast Health Center
New Bern, North Carolina, 28560, United States
Rex Healthcare
Raleigh, North Carolina, 27607, United States
Sanford Research/USD/Sanford Clinic
Fargo, North Dakota, 58122, United States
Riverside Methodist Hospital / MidWest Cardiology Research Foundation
Columbus, Ohio, 43214, United States
Holy Spirit Hospital
Camp Hill, Pennsylvania, 17011, United States
Allegheny General Hospital/Forbes Hospital
Pittsburgh, Pennsylvania, 15146, United States
Miriam Hospital
Providence, Rhode Island, 02904, United States
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231, United States
Sentara Vascular Specialists
Norfolk, Virginia, 23507, United States
Providence Sacred Heart Medical Center / Providence Spokane Cardiology
Spokane, Washington, 99204, United States
Wisconsin Heart Hospital
Milwaukee, Wisconsin, 53212, United States
Aurora St. Luke's Medical Center / Aurora Medical Group
Milwaukee, Wisconsin, 53215, United States
Imelda Hospital / Flanders Medical Research Program
Bonheiden, 2820, Belgium
A.Z. Sint-Blasius Hospital / Flanders Medical Research Program
Dendermonde, 9220, Belgium
Related Publications (1)
Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.
PMID: 17377972BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William A. Gray, MD
Center for Interventional Vascular Therapy / Columbia University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 18, 2011
Study Start
September 16, 2011
Primary Completion
January 15, 2016
Study Completion
April 10, 2018
Last Updated
June 29, 2018
Record last verified: 2018-06