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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Peripheral Vascular Disease; Peripheral Artery Disease; Vascular Disease; PAD
• Intervention / Treatment: Device: FlexStent® Femoropopliteal Self Expanding Stent System

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Collaborators: Massachusetts General Hospital; Prairie Education and Research Cooperative
• Investigators: Principal Investigator: William A. Gray, MD, Center for Interventional Vascular Therapy / Columbia University Medical Center

Publications and helpful links

General 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. doi: 10.1002/ccd.21104.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2011
• Primary Completion (Actual): January 15, 2016
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 18, 2011

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Stent; Bare Metal Stent; FlexStent; Superficial Femoral Artery or SFA; Self Expanding Stent
• Additional Relevant MeSH Terms: Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Cardiovascular Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FSS-0003