Back to resultsEvaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System (OPEN)
Primary Purpose
Peripheral Artery Disease, Peripheral Vascular Disease, Vascular Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FlexStent® Femoropopliteal Self Expanding Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease focused on measuring FlexStent, Superficial Femoral Artery or SFA, Self Expanding Stent, Stent, Bare Metal Stent
Eligibility Criteria
Inclusion Criteria:
All subjects must meet the following criteria:
- 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.
- 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 ≤ 180 mm
- >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
Sites / Locations
- Abrazo Health Care Clinical & Trans. Research
- Yuma Regional Medical Center
- El Camino Hospital
- Yale University/New Haven Hospital
- Manatee Memorial Hospital
- Florida Research Network
- Memorial Hospital
- Mount Sinai Miami Medical Center
- Baptist Cardiac & Vascular Institute
- Florida Hospital Pepin Heart Institute
- University Hospital
- St. John's Hospital
- Midwest Cardiovascular Research Foundation / Trinity Medical Center
- Healient Physician Group
- Lafayette General Medical Center
- Christus St. Patrick Hospital
- Glenwood Regional Medical Center
- Washington Adventist Hospital / Center for Cardiac & Vascular Research
- Deborah Heart
- Cardiovascular Associates of the Delaware Valley
- Our Lady of Lourdes Medical Center
- Holy Name Medical Center
- Gotham Cardiovascular Research, PC
- Columbia University Medical Center, Center for Interventional Vascular Therapy
- CarolinaEast Health Center
- Rex Healthcare
- Sanford Research/USD/Sanford Clinic
- Riverside Methodist Hospital / MidWest Cardiology Research Foundation
- Holy Spirit Hospital
- Allegheny General Hospital/Forbes Hospital
- Miriam Hospital
- Cardiovascular Research Institute of Dallas
- Sentara Vascular Specialists
- Providence Sacred Heart Medical Center / Providence Spokane Cardiology
- Wisconsin Heart Hospital
- Aurora St. Luke's Medical Center / Aurora Medical Group
- Imelda Hospital / Flanders Medical Research Program
- A.Z. Sint-Blasius Hospital / Flanders Medical Research Program
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PAD
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01355406
First Posted
May 16, 2011
Last Updated
June 27, 2018
Sponsor
Cordis Corporation
Collaborators
Massachusetts General Hospital, Prairie Education and Research Cooperative
1. Study Identification
Unique Protocol Identification Number
NCT01355406
Brief Title
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
Acronym
OPEN
Official Title
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2011 (Actual)
Primary Completion Date
January 15, 2016 (Actual)
Study Completion Date
April 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cordis Corporation
Collaborators
Massachusetts General Hospital, Prairie Education and Research Cooperative
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Peripheral Vascular Disease, Vascular Disease, Cardiovascular Diseases, PAD
Keywords
FlexStent, Superficial Femoral Artery or SFA, Self Expanding Stent, Stent, Bare Metal Stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAD
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
FlexStent® Femoropopliteal Self Expanding Stent System
Other Intervention Name(s)
FlexStent®, OPEN
Intervention Description
Transcatheter over guidewire placement of an intravascular stent(s)
Primary Outcome Measure Information:
Title
The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days.
Description
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.
Time Frame
30 Days
Title
The primary efficacy endpoint is vessel patency at 12 months.
Description
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.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All subjects must meet the following criteria:
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.
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 ≤ 180 mm
>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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William A. Gray, MD
Organizational Affiliation
Center for Interventional Vascular Therapy / Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abrazo Health Care Clinical & Trans. Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Yuma Regional Medical Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Yale University/New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Manatee Memorial Hospital
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Florida Research Network
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Memorial Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Mount Sinai Miami Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Baptist Cardiac & Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Hospital Pepin Heart Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
Midwest Cardiovascular Research Foundation / Trinity Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Healient Physician Group
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Lafayette General Medical Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Christus St. Patrick Hospital
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Glenwood Regional Medical Center
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Washington Adventist Hospital / Center for Cardiac & Vascular Research
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Deborah Heart
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Our Lady of Lourdes Medical Center
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Gotham Cardiovascular Research, PC
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Columbia University Medical Center, Center for Interventional Vascular Therapy
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
CarolinaEast Health Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28560
Country
United States
Facility Name
Rex Healthcare
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Sanford Research/USD/Sanford Clinic
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Riverside Methodist Hospital / MidWest Cardiology Research Foundation
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Holy Spirit Hospital
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Allegheny General Hospital/Forbes Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Cardiovascular Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Sentara Vascular Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Providence Sacred Heart Medical Center / Providence Spokane Cardiology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Wisconsin Heart Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States
Facility Name
Aurora St. Luke's Medical Center / Aurora Medical Group
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Imelda Hospital / Flanders Medical Research Program
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
A.Z. Sint-Blasius Hospital / Flanders Medical Research Program
City
Dendermonde
ZIP/Postal Code
9220
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
17377972
Citation
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.
Results Reference
background
Learn more about this trial
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
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