Clinical trial NCT01355406: Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
Official title: Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Vascular Disease
Cardiovascular Diseases
PAD
Keywords: FlexStent
Superficial Femoral Artery or SFA
Self Expanding Stent
Stent
Bare Metal Stent
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: Prairie Education and Research Cooperative
First posted: 2011-05-18
Enrollment: 257
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

All subjects must meet the following criteria:

1. 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.
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. 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
5. Disease segment length ≤ 180 mm
6. \>70% diameter stenosis and/or occlusion based on site-determined visual angiography
7. Patent ipsilateral iliac artery
8. Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention
9. Target reference vessel diameter 3.5-7.5 mm.
10. Projected life expectancy of 12 months or greater
11. Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements
12. 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.

1. Target vessel previously treated with a stent
2. Target lesion within 1.5 cm of the ostium of the SFA
3. Rutherford Classification Category 0,1,5 or 6
4. Inability to tolerate antithrombotic or antiplatelet therapies
5. Pregnancy (female of child-bearing age confirmed pregnant)
6. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
7. Serum creatinine \> 2.5 mg/dL
8. Myocardial infarction or stroke within 30 days of treatment date
9. Known hypercoagulable state
10. Known bleeding diathesis
11. Untreated angiographically-evident thrombus in target vessel
12. Patients currently enrolled in any other clinical trial

Primary outcomes:
measure: The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days.
timeFrame: 30 Days
measure: The primary efficacy endpoint is vessel patency at 12 months.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Abrazo Health Care Clinical & Trans. Research
state: Arizona
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: New Haven
country: United States
facility: Yale University/New Haven Hospital
state: Connecticut
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Gainesville
country: United States
facility: Florida Research Network
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Miami Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac & Vascular Institute
state: Florida
city: Tampa
country: United States
facility: Florida Hospital Pepin Heart Institute
state: Florida
city: Augusta
country: United States
facility: University Hospital
state: Georgia
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation / Trinity Medical Center
state: Iowa
city: Overland Park
country: United States
facility: Healient Physician Group
state: Kansas
city: Lafayette
country: United States
facility: Lafayette General Medical Center
state: Louisiana
city: Lake Charles
country: United States
facility: Christus St. Patrick Hospital
state: Louisiana
city: West Monroe
country: United States
facility: Glenwood Regional Medical Center
state: Louisiana
city: Takoma Park
country: United States
facility: Washington Adventist Hospital / Center for Cardiac & Vascular Research
state: Maryland
city: Browns Mills
country: United States
facility: Deborah Heart
state: New Jersey
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Haddon Heights
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: Gotham Cardiovascular Research, PC
state: New York
city: New York
country: United States
facility: Columbia University Medical Center, Center for Interventional Vascular Therapy
state: New York
city: New Bern
country: United States
facility: CarolinaEast Health Center
state: North Carolina
city: Raleigh
country: United States
facility: Rex Healthcare
state: North Carolina
city: Fargo
country: United States
facility: Sanford Research/USD/Sanford Clinic
state: North Dakota
city: Columbus
country: United States
facility: Riverside Methodist Hospital / MidWest Cardiology Research Foundation
state: Ohio
city: Camp Hill
country: United States
facility: Holy Spirit Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital/Forbes Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Dallas
country: United States
facility: Cardiovascular Research Institute of Dallas
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center / Providence Spokane Cardiology
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Heart Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center / Aurora Medical Group
state: Wisconsin
city: Bonheiden
country: Belgium
facility: Imelda Hospital / Flanders Medical Research Program
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius Hospital / Flanders Medical Research Program
Study officials:
affiliation: Center for Interventional Vascular Therapy / Columbia University Medical Center
name: William A. Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.