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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Cordis Corporation
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: December 12, 2013
Last verified: December 2013

May 16, 2011
December 12, 2013
September 2011
June 2015   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT01355406 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Artery Disease
  • Peripheral Vascular Disease
  • Vascular Disease
  • Cardiovascular Diseases
  • PAD
Device: FlexStent® Femoropopliteal Self Expanding Stent System
Transcatheter over guidewire placement of an intravascular stent(s)
Other Names:
  • FlexStent®
  • OPEN
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.
Intervention: Device: FlexStent® Femoropopliteal Self Expanding Stent System
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
257
June 2017
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

All subjects must meet the following criteria:

  1. 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.
  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 ≤ 145mm
  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
Both
35 Years to 80 Years
No
United States,   Belgium
 
NCT01355406
FSS-0003
Yes
Cordis Corporation
Cordis Corporation
  • Massachusetts General Hospital
  • Prairie Education and Research Cooperative
Principal Investigator: William A. Gray, MD Center for Interventional Vascular Therapy / Columbia University Medical Center
Cordis Corporation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP