Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System (OPEN)
This study is currently recruiting participants.
Verified October 2011 by Flexible Stenting Solutions, Inc.
Sponsor:
Flexible Stenting Solutions, Inc.
Collaborators:
Massachusetts General Hospital
Prairie Education and Research Cooperative
Information provided by (Responsible Party):
Flexible Stenting Solutions, Inc.
ClinicalTrials.gov Identifier:
NCT01355406
First received: May 16, 2011
Last updated: October 19, 2011
Last verified: October 2011
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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 Flexible Stenting Solutions, Inc.:
Primary Outcome Measures:
- The primary safety endpoint will be a composite of all death, TLR, or index limb amputation. [ 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 will be vessel patency at 12 months, defined as freedom from greater than 50% restenosis. [ 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.
| Estimated Enrollment: | 227 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: FlexStent® Femoropopliteal Self Expanding Stent System
- FlexStent®
- OPEN
Transcatheter over guidewire placement of an intravascular stent(s)
Other Names:
Eligibility| Ages Eligible for Study: | 35 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
All subjects must meet the following criteria:
- Subjects, male or female, must be between the ages of 35 to 80 years inclusive 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.
- 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.
- Rutherford Classification Category 2-4
- 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
- Disease segment length ≤ 145mm
- >70% diameter stenosis and/or occlusion based on site-determined visual angiography
- Patent ipsilateral iliac artery
- Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention
- Target reference vessel diameter 3.5-7.5 mm.
- Projected life expectancy of 12 months or greater
- Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements
- 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.
- Target vessel previously treated with a stent
- Target lesion within 1.5 cm of the ostium of the SFA
- Rutherford Classification Category 0,1,5 or 6
- Inability to tolerate antithrombotic or antiplatelet therapies
- Pregnancy (female of child-bearing age confirmed pregnant)
- Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
- Serum creatinine > 2.5 mg/dL
- Myocardial infarction or stroke within 30 days of treatment date
- Known hypercoagulable state
- Known bleeding diathesis
- Untreated angiographically-evident thrombus in target vessel
- Patients currently enrolled in any other clinical trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355406
Locations
| United States, Florida | |
| Florida Research Network | Recruiting |
| Gainesville, Florida, United States, 32605 | |
| Contact: Kurt D. Malphurs, RN, BSN 352-333-0939 kurtm@flrnetwork.com | |
| Principal Investigator: Bret N. Wiechmann, M.D. | |
| Mount Sinai Miami Medical Center | Recruiting |
| Miami Beach, Florida, United States, 33140 | |
| Contact: Nancy Cabrera, CCRP 305-674-2121 | |
| Principal Investigator: Robert Beasley, M.D. | |
| United States, Iowa | |
| Midwest Cardiovascular Research Foundation / Trinity Medical Center | Recruiting |
| Davenport, Iowa, United States, 52803 | |
| Contact: Desyree V. Weakley, RN 563-324-4384 ext 7 weakleyd@mcrfmd.com | |
| Contact: Penny L. Stokes, RN, BS 563-324-4384 ext 2 stoakesp@mcrfmd.com | |
| Principal Investigator: Eric J. Dippel, M.D. | |
| United States, Maryland | |
| Washington Adventist Hospital / Center for Cardiac & Vascular Research | Recruiting |
| Takoma Park, Maryland, United States, 20912 | |
| Contact: Dawn E. Shaddinger, RN, MSN CCRC 301-891-5612 | |
| Contact: Patricia A. Miller 301-891-5405 pmiller2@aventisthealthcare.com | |
| Principal Investigator: Fayaz Shawl, M.D., FACP | |
| United States, New York | |
| Columbia University Medical Center, Center for Interventional Vascular Therapy | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Zumara De La Cruz 212-342-3481 zd2129@columbia.edu | |
| Contact: Kate Dalton 212-342-3481 keb2114@mail.cumc.columbia.edu | |
| Principal Investigator: William A. Gray, M.D. | |
| United States, Ohio | |
| OhioHealth Research Institute | Recruiting |
| Columbus, Ohio, United States, 43214 | |
| Contact: Marcy Hawkins, RN, CCRC 614-566-1250 | |
| Contact: Nancy S. Sample, RN, CCRC 614-566-1267 nsample@ohiohealth.com | |
| Principal Investigator: Mitchell J. Silver, D.O., FACC | |
| United States, Pennsylvania | |
| Spirit Physician Services / Capital Cardiovascular Associates / Holy Spirit Hospital | Recruiting |
| Camp Hill, Pennsylvania, United States, 17011 | |
| Contact: Roxanne Yost, RN, BS 717-724-6450 | |
| Principal Investigator: Rajesh M. Dave, M.D., FACC | |
| United States, Washington | |
| Providence Sacred Heart Medical Center / Providence Spokane Cardiology | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Jill Ciccarello 509-455-8820 jciccarello@spokanecardiology.com | |
| Principal Investigator: Pierre Leimgruber, M.D. | |
| United States, Wisconsin | |
| Aurora St. Luke's Medical Center / Aurora Medical Group | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Valerie J. Zindars, RN 414-649-6853 | |
| Contact: Christina M. Schreiter, BSN 414-385-2472 | |
| Principal Investigator: Mark W. Mewissen, M.D. | |
| Belgium | |
| Imelda Hospital / Flanders Medical Research Program | Recruiting |
| Bonheiden, Belgium, 2820 | |
| Contact: Wendy Janssens +32 15 50 61 82 cardvasc1@imelda.be | |
| Principal Investigator: Patrick Peeters, MAJJ | |
| A.Z. Sint-Blasius Hospital / Flanders Medical Research Program | Recruiting |
| Dendermonde, Belgium, 9220 | |
| Contact: Erwin Vinck +32 52 25 27 35 erwin.vinck@fmrp.be | |
| Principal Investigator: Marc Bosiers, M.D. | |
Sponsors and Collaborators
Flexible Stenting Solutions, Inc.
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: | Flexible Stenting Solutions, Inc. |
| ClinicalTrials.gov Identifier: | NCT01355406 History of Changes |
| Other Study ID Numbers: | FSS-0003 |
| Study First Received: | May 16, 2011 |
| Last Updated: | October 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Flexible Stenting Solutions, Inc.:
|
FlexStent Superficial Femoral Artery or SFA Self Expanding Stent Stent Bare Metal Stent |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease |
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 16, 2013