Peripheral Artery DiseaseOPENNCT01355406
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
A study testing FlexStent® Femoropopliteal Self Expanding Stent System in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Cordis US Corp. at 38 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Peripheral Artery Disease, Peripheral Vascular Disease, Vascular Disease
- What is being tested?
- FlexStent® Femoropopliteal Self Expanding Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 38 sitesin 2 countries
- Study dates
- 16 Sep 2011to 10 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- >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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States36 sites
University Hospital
Augusta, Georgia, 30901
Manatee Memorial Hospital
Bradenton, Florida, 34205
Deborah Heart
Browns Mills, New Jersey, 08015
Holy Spirit Hospital
Camp Hill, Pennsylvania, 17011
Riverside Methodist Hospital / MidWest Cardiology Research Foundation
Columbus, Ohio, 43214
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231
Midwest Cardiovascular Research Foundation / Trinity Medical Center
Davenport, Iowa, 52803
Sanford Research/USD/Sanford Clinic
Fargo, North Dakota, 58122
Florida Research Network
Gainesville, Florida, 32605
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08103
Our Lady of Lourdes Medical Center
Haddon Heights, New Jersey, 08103
Memorial Hospital
Jacksonville, Florida, 32256
Lafayette General Medical Center
Lafayette, Louisiana, 70506
Christus St. Patrick Hospital
Lake Charles, Louisiana, 70601
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176
Mount Sinai Miami Medical Center
Miami Beach, Florida, 33140
Wisconsin Heart Hospital
Milwaukee, Wisconsin, 53212
Aurora St. Luke's Medical Center / Aurora Medical Group
Milwaukee, Wisconsin, 53215
El Camino Hospital
Mountain View, California, 94040
CarolinaEast Health Center
New Bern, North Carolina, 28560
Yale University/New Haven Hospital
New Haven, Connecticut, 06510
Gotham Cardiovascular Research, PC
New York, New York, 10001
Columbia University Medical Center, Center for Interventional Vascular Therapy
New York, New York, 10032
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Healient Physician Group
Overland Park, Kansas, 66211
Abrazo Health Care Clinical & Trans. Research
Phoenix, Arizona, 85006
Allegheny General Hospital/Forbes Hospital
Pittsburgh, Pennsylvania, 15146
Miriam Hospital
Providence, Rhode Island, 02904
Rex Healthcare
Raleigh, North Carolina, 27607
Providence Sacred Heart Medical Center / Providence Spokane Cardiology
Spokane, Washington, 99204
St. John's Hospital
Springfield, Illinois, 62769
Washington Adventist Hospital / Center for Cardiac & Vascular Research
Takoma Park, Maryland, 20912
Florida Hospital Pepin Heart Institute
Tampa, Florida, 33613
Holy Name Medical Center
Teaneck, New Jersey, 07666
Glenwood Regional Medical Center
West Monroe, Louisiana, 71291
Yuma Regional Medical Center
Yuma, Arizona, 85364
Belgium2 sites
Imelda Hospital / Flanders Medical Research Program
Bonheiden, 2820
A.Z. Sint-Blasius Hospital / Flanders Medical Research Program
Dendermonde, 9220
About this study
Official title: 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.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Vascular Disease, Cardiovascular Diseases, PAD
- Being tested
- FlexStent® Femoropopliteal Self Expanding Stent System
- Keywords
- FlexStent, Superficial Femoral Artery or SFA, Self Expanding Stent, Stent, Bare Metal Stent
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexStent® Femoropopliteal Self Expanding Stent SystemDevice
Also called FlexStent®, OPEN
Transcatheter over guidewire placement of an intravascular stent(s)
| Study group | Role | What they receive |
|---|---|---|
| PAD | Other | 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. Receives: Device: FlexStent® Femoropopliteal Self Expanding Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study start16 Sep 2011
- Primary completion15 Jan 2016
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Prairie Education and Research Cooperative
- Responsible party
- Sponsor
- Investigators
- William A. Gray, MD, Principal investigator, Center for Interventional Vascular Therapy / Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355406
- Sponsor's protocol ID
- FSS-0003
- Acronym
- OPEN
- Status last verified
- Jun 2018
- First submitted
- 16 May 2011
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17377972
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study
- ClinicalTrials.gov ID
- NCT01355406
- Acronym / sponsor ID
- OPEN / FSS-0003
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Prairie Education and Research Cooperative
- Study start
- 16 Sep 2011 (actual)
- Primary completion
- 15 Jan 2016 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD | Other | Device: FlexStent® Femoropopliteal Self Expanding Stent SystemThis 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlexStent® Femoropopliteal Self Expanding Stent SystemAlso: FlexStent®, OPENTranscatheter over guidewire placement of an intravascular stent(s) | Device | PAD |
Primary outcome
The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days.
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Background: PubMed 17377972Rocha-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William A. Gray, MD principal investigator
Center for Interventional Vascular Therapy / Columbia University Medical Center
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlexStent® Femoropopliteal Self Expanding Stent System in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Cordis US Corp. at 38 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days. (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01355406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.