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

• Sponsor: Cordis Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01355406
• Collaborator: Massachusetts General Hospital (Other), Prairie Education and Research Cooperative (Industry)
• Enrollment: 257
• Locations: 38
• Arm: 1
• Actual Duration (Months): 78.8
• Patients Per Site: 6.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease; Peripheral Vascular Disease; Vascular Disease; Cardiovascular Diseases; PAD	Device: FlexStent® Femoropopliteal Self Expanding Stent System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 257 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study
• Actual Study Start Date: Sep 16, 2011
• Actual Primary Completion Date: Jan 15, 2016
• Actual Study Completion Date: Apr 10, 2018

Arms and Interventions

Arm

Intervention/Treatment

Other: PAD 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.

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abrazo Health Care Clinical & Trans. Research	Phoenix	Arizona	United States	85006
2	Yuma Regional Medical Center	Yuma	Arizona	United States	85364
3	El Camino Hospital	Mountain View	California	United States	94040
4	Yale University/New Haven Hospital	New Haven	Connecticut	United States	06510
5	Manatee Memorial Hospital	Bradenton	Florida	United States	34205
6	Florida Research Network	Gainesville	Florida	United States	32605
7	Memorial Hospital	Jacksonville	Florida	United States	32256
8	Mount Sinai Miami Medical Center	Miami Beach	Florida	United States	33140
9	Baptist Cardiac & Vascular Institute	Miami	Florida	United States	33176
10	Florida Hospital Pepin Heart Institute	Tampa	Florida	United States	33613
11	University Hospital	Augusta	Georgia	United States	30901
12	St. John's Hospital	Springfield	Illinois	United States	62769
13	Midwest Cardiovascular Research Foundation / Trinity Medical Center	Davenport	Iowa	United States	52803
14	Healient Physician Group	Overland Park	Kansas	United States	66211
15	Lafayette General Medical Center	Lafayette	Louisiana	United States	70506
16	Christus St. Patrick Hospital	Lake Charles	Louisiana	United States	70601
17	Glenwood Regional Medical Center	West Monroe	Louisiana	United States	71291
18	Washington Adventist Hospital / Center for Cardiac & Vascular Research	Takoma Park	Maryland	United States	20912
19	Deborah Heart	Browns Mills	New Jersey	United States	08015
20	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey	United States	08103
21	Our Lady of Lourdes Medical Center	Haddon Heights	New Jersey	United States	08103
22	Holy Name Medical Center	Teaneck	New Jersey	United States	07666
23	Gotham Cardiovascular Research, PC	New York	New York	United States	10001
24	Columbia University Medical Center, Center for Interventional Vascular Therapy	New York	New York	United States	10032
25	CarolinaEast Health Center	New Bern	North Carolina	United States	28560
26	Rex Healthcare	Raleigh	North Carolina	United States	27607
27	Sanford Research/USD/Sanford Clinic	Fargo	North Dakota	United States	58122
28	Riverside Methodist Hospital / MidWest Cardiology Research Foundation	Columbus	Ohio	United States	43214
29	Holy Spirit Hospital	Camp Hill	Pennsylvania	United States	17011
30	Allegheny General Hospital/Forbes Hospital	Pittsburgh	Pennsylvania	United States	15146
31	Miriam Hospital	Providence	Rhode Island	United States	02904
32	Cardiovascular Research Institute of Dallas	Dallas	Texas	United States	75231
33	Sentara Vascular Specialists	Norfolk	Virginia	United States	23507
34	Providence Sacred Heart Medical Center / Providence Spokane Cardiology	Spokane	Washington	United States	99204
35	Wisconsin Heart Hospital	Milwaukee	Wisconsin	United States	53212
36	Aurora St. Luke's Medical Center / Aurora Medical Group	Milwaukee	Wisconsin	United States	53215
37	Imelda Hospital / Flanders Medical Research Program	Bonheiden		Belgium	2820
38	A.Z. Sint-Blasius Hospital / Flanders Medical Research Program	Dendermonde		Belgium	9220

Sponsors and Collaborators

• Cordis Corporation
• Massachusetts General Hospital
• Prairie Education and Research Cooperative

Investigators

• Principal Investigator: William A. Gray, MD, Center for Interventional Vascular Therapy / Columbia University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Cordis Corporation
• ClinicalTrials.gov Identifier: NCT01355406
• Other Study ID Numbers: FSS-0003
• First Posted: May 18, 2011
• Last Update Posted: Jun 29, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Cordis Corporation: FlexStent; Superficial Femoral Artery or SFA; Self Expanding Stent; Stent; Bare Metal Stent
• Additional relevant MeSH terms: Cardiovascular Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases

Study Results

No Results Posted as of Jun 29, 2018