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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Prairie Education and Research Cooperative
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT01355406
First received: May 16, 2011
Last updated: January 22, 2015
Last verified: January 2015
  Purpose

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 Intervention
Peripheral Artery Disease
Peripheral Vascular Disease
Vascular Disease
Cardiovascular Diseases
PAD
Device: FlexStent® Femoropopliteal Self Expanding Stent System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    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.

  • The primary efficacy endpoint is vessel patency at 12 months. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 257
Study Start Date: September 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355406

Locations
United States, Florida
Florida Research Network
Gainesville, Florida, United States, 32605
Mount Sinai Miami Medical Center
Miami Beach, Florida, United States, 33140
United States, Iowa
Midwest Cardiovascular Research Foundation / Trinity Medical Center
Davenport, Iowa, United States, 52803
United States, Maryland
Washington Adventist Hospital / Center for Cardiac & Vascular Research
Takoma Park, Maryland, United States, 20912
United States, New York
Columbia University Medical Center, Center for Interventional Vascular Therapy
New York, New York, United States, 10032
United States, Ohio
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Spirit Physician Services / Capital Cardiovascular Associates / Holy Spirit Hospital
Camp Hill, Pennsylvania, United States, 17011
United States, Washington
Providence Sacred Heart Medical Center / Providence Spokane Cardiology
Spokane, Washington, United States, 99204
United States, Wisconsin
Aurora St. Luke's Medical Center / Aurora Medical Group
Milwaukee, Wisconsin, United States, 53215
Belgium
Imelda Hospital / Flanders Medical Research Program
Bonheiden, Belgium, 2820
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
  More Information

Publications:
Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT01355406     History of Changes
Other Study ID Numbers: FSS-0003
Study First Received: May 16, 2011
Last Updated: January 22, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cordis Corporation:
FlexStent
Superficial Femoral Artery or SFA
Self Expanding Stent
Stent
Bare Metal Stent

Additional relevant MeSH terms:
Cardiovascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis

ClinicalTrials.gov processed this record on August 04, 2015