Peripheral Arterial DiseaseTIGRISNCT01576055
Evaluation of the GORE TIGRIS Vascular Stent
A study testing TIGRIS Vascular Stent and BARD LifeStent in people with Peripheral Arterial Disease, run by W.L.Gore & Associates at 34 sites in United States.
Trial summary
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- TIGRIS Vascular Stent and BARD LifeStent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 34 sitesUnited States
- Study dates
- Apr 2012to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rutherford Class 2 - 4.
- Abnormal ankle brachial index (ABI ≤0.9).
- At least 21 years of age.
- Reasonable expectation of survival of at least 12 months after the procedure.
- Male, infertile female, or female practicing an effective method of preventing pregnancy.
- One de novo or restenotic lesion of the SFA/PPA with a cumulative length visually estimated to be ≤24cm
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- Arteries with reference vessel diameter of 4.0 - 6.5 mm within the SFA/PPA, estimated visually.
- Angiographic evidence of at least one patent tibial artery (<50% stenosis angiographically).
- Guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel.
- Lesion has been pre-dilated before stent deployment.
Who cannot join
- Prior enrollment in this study.
- Vascular access/catheterization in the target leg within 30 days of study enrollment.
- Prior treatment of the SFA/PPA in the target leg with stenting or bypass.
- Flow-limiting aortoiliac disease.
- Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention.
- Arterial aneurysm in the target leg.
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- Co-morbid conditions which would preclude compliance with study protocol.
- Obstructive or occlusive non-atherosclerotic disease.
- Creatinine greater than 2.5 mg/dl.
- Amputation above the metatarsals, resulting from vascular disease, in the target leg.
- Septicemia or uncontrolled infection.
- Contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (HIT), or a positive platelet factor 4 (PF4) antibody assay.
- Abnormal platelet levels, i.e., platelet count at Baseline less than 80,000/microliter.
- History of coagulopathy.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Vascular Surgical Associates, PC
Austell, Georgia, 30106
Heritage Valley Health System
Beaver, Pennsylvania, 15009
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, 25304
Northwestern University
Chicago, Illinois, 60611
Ohio Health Research Institute
Columbus, Ohio, 43214
Baylor Research Institute
Dallas, Texas, 75093
Presbyterian Hospital, Dallas
Dallas, Texas, 75231
Genesis Medical Center
Davenport, Iowa, 52803
Alexian Brothers Specialty Group
Elk Grove Village, Illinois, 60007
Kaiser Permanente - Honolulu
Honolulu, Hawaii, 96817
Indiana University Vascular Surgery
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
First Coast Cardiovascular Institute, P.A
Jacksonville, Florida, 32216
Arkansas Heart
Little Rock, Arkansas, 72211
Medical Center of Central Georgia
Macon, Georgia, 31201
Minneapolis Radiology and Vascular
Minneapolis, Minnesota, 55441
Cardiology Associates of Mobile
Mobile, Alabama, 36532
Heart Care Research Foundation
Mokena, Illinois, 60448
Vascular Research Institute
Morristown, New Jersey, 07960
Yale University School of Medicine
New Haven, Connecticut, 06520
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
MediQuest Research at Munroe Regional
Ocala, Florida, 34471
North County Radiology
Oceanside, California, 92056
Orlando Regional Healthcare System
Orlando, Florida, 32806
Coastal Vascular & Interventional
Pensacola, Florida, 32504
HeartCare MidWest - Peoria
Peoria, Illinois, 61614
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Providence Heat & Vascular Institute
Portland, Oregon, 97225
The Miriam Hospital
Providence, Rhode Island, 02906
UC Davis Vascular Center
Sacramento, California, 95817
SSM Health Care
Saint Charles, Missouri, 63301
Kaiser Permanente San Francisco
San Francisco, California, 94118
North Central Heart Institute, Ltd.
Sioux Falls, South Dakota, 57108
About this study
Official title: Evaluation of the GORE TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).
- Conditions
- Peripheral Arterial Disease
- Being tested
- TIGRIS Vascular Stent, BARD LifeStent
- Keywords
- Peripheral Arterial Disease, Superficial Femoral Artery, Proximal Popliteal Artery, PAD, SFA, PPA, Stent, Gore, Bare Metal Stent, LifeStent, atherosclerosis, Heparin, claudication, leg pain
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIGRIS Vascular StentDevice
Implant
BARD LifeStentDevice
Implant
| Study group | Role | What they receive |
|---|---|---|
| TIGRIS Vascular Stent | Experimental | GORE TIGRIS Vascular Stent Receives: Device: TIGRIS Vascular Stent |
| BARD LifeStent | Active comparator | BARD LifeStent Receives: Device: BARD LifeStent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days
Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).
Measured: 30 Days
Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months
Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.
Measured: 12 Months
Secondary outcomes (2)
Number of Participants With Procedural Success
Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.
Measured: Within 48 hours of initial device implant
Number of Participants With Device Success
Successful delivery of stent to the intended site and successful stent deployment.
Measured: Immediately following initial device implant (usually within a few minutes to an hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2015
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Laird, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576055
- Sponsor's protocol ID
- PCE 09-02
- Acronym
- TIGRIS
- Status last verified
- Sep 2017
- First submitted
- 29 Mar 2012
- Last updated
- 9 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GORE TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries
- ClinicalTrials.gov ID
- NCT01576055
- Acronym / sponsor ID
- TIGRIS / PCE 09-02
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Superficial Femoral Artery, Proximal Popliteal Artery, PAD, SFA, PPA, Stent, Gore
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Posted 19 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIGRIS Vascular Stent | Experimental | Device: TIGRIS Vascular StentGORE TIGRIS Vascular Stent |
| BARD LifeStent | Active comparator | Device: BARD LifeStentBARD LifeStent |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Rutherford Class 2 - 4.
- Abnormal ankle brachial index (ABI ≤0.9).
- At least 21 years of age.
- Reasonable expectation of survival of at least 12 months after the procedure.
- Male, infertile female, or female practicing an effective method of preventing pregnancy.
Key exclusion criteria (14 listed)
- Prior enrollment in this study.
- Vascular access/catheterization in the target leg within 30 days of study enrollment.
- Prior treatment of the SFA/PPA in the target leg with stenting or bypass.
- Flow-limiting aortoiliac disease.
- Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention.
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 |
|---|---|---|
| TIGRIS Vascular StentImplant | Device | TIGRIS Vascular Stent |
| BARD LifeStentImplant | Device | BARD LifeStent |
Primary outcome
Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days
Time frame: 30 Days
Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).
Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months
Time frame: 12 Months
Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.
2 secondary outcomes
Number of Participants With Procedural Success
Time frame: Within 48 hours of initial device implant
Number of Participants With Device Success
Time frame: Immediately following initial device implant (usually within a few minutes to an hour).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John Laird, MD principal investigator
UC Davis
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIGRIS Vascular Stent and BARD LifeStent in people with Peripheral Arterial Disease, run by W.L.Gore & Associates at 34 sites in United States.
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 10 inclusion and 14 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 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?
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 9 Oct 2017.