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

Cardiovascular Diseases Clinical Trial

— OPEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355406
• Other study ID #: FSS-0003
• Status: Completed
• Phase: N/A
• Start date: September 16, 2011
• Est. completion date: April 10, 2018

Study information

• Verified date: June 2018
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: April 10, 2018
• Est. primary completion date: January 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• PAD
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Disease
• Vascular Diseases

Intervention

Device:
• FlexStent® Femoropopliteal Self Expanding Stent System
Transcatheter over guidewire placement of an intravascular stent(s)

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Cordis Corporation	Massachusetts General Hospital, Prairie Education and Research Cooperative

Countries where clinical trial is conducted

United States,  Belgium, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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