Intermittent ClaudicationRESILIENTNCT00673985
Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study
A study testing Percutaneous Transluminal Angioplasty and LifeStent NT™ Self-Expanding Peripheral Stent in people with Intermittent Claudication and Atherosclerotic Disease, run by C. R. Bard.
Trial summary
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication, Atherosclerotic Disease, Arterial Occlusive Disease
- What is being tested?
- Percutaneous Transluminal Angioplasty and LifeStent NT™ Self-Expanding Peripheral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Oct 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent approved by the IRB.
- ≥ 18 years old.
- Lifestyle-limiting claudication defined as: Rutherford Cat. 1-3.
- Target lesion(s) is de-novo or restenotic and located within the native SFA and/or proximal popliteal artery
- Angiographic evidence of ≥ 50% stenosis or occlusion
- Target RVD is ≥ 4.0 mm and ≤ 7.0 mm
- Target total length of the lesion or series of lesions is ≤ 150 mm.
- Angiographic evidence of at least one vessel runoff to the foot.
Who cannot join
- Unable to conform to the study protocol procedures and visits.
- Lifestyle-limiting claudication/CLI (Rutherford Cat. 4-6)
- Patients who are pregnant or planning to become pregnant during the clinical investigation
- Contraindication to study related medications, Ni, Ti, Ta, or other media that is not amenable to pretreatment.
- History of bleeding diatheses or coagulopathy.
- Concomitant renal failure with a creatinine of > 2.0 mg/dL.
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- Concomitant hepatic insufficiency, thrombophlebitis, uremia, SLE, or DVT at the time of the study procedure.
- Receiving dialysis or immunosuppressive therapy.
- Suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure.
- Prior peripheral vascular bypass surgery involving the target limb.
- Target vessel has been previously stented.
- Target lesion(s) received angioplasty intervention ≤ 6 mo. prior
- Any non-iliac percutaneous intervention(s) < 7 days prior.
- Currently participating in an investigational drug/device study.
- Limited life expectancy of less than two years.
- Extensive PVD that precludes safe insertion of an sheath.
- Target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
- Unresolved thrombus within the target vessel.
- Poor inflow which would not support a vascular bypass graft.
- Diagnosed with septicemia at the time of the study procedure.
- Additional percutaneous interventional procedures (cardiac/peripheral) planned ≤ 30 days following procedure.
About this study
Official title: A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone
Read the detailed description
The RESILIENT Trial is a dual stage clinical investigation designed to evaluate the safety and effectiveness of the Edwards Lifesciences self-expanding stent system.
Phase 1 consists of a prospective, multi-center, non-randomized study with a peri-procedure endpoint. Phase 2 consists of a prospective, multi-center, randomized study with a 30-day primary safety endpoint and a 6-month primary effectiveness endpoint.
- Being tested
- Percutaneous Transluminal Angioplasty, LifeStent NT™ Self-Expanding Peripheral Stent
- Keywords
- SFA, Edwards, Popliteal, LifeStent, PTA, Nitinol
- Medical subject headings
- Intermittent Claudication, Arterial Occlusive Diseases, Truncus Arteriosus, Persistent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Transluminal AngioplastyOther
Balloon Angioplasty
LifeStent NT™ Self-Expanding Peripheral StentDevice
Balloon angioplasty plus stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PTA Only: Active Comparator
Percutaneous transluminal angioplasty (PTA) alone Receives: Other: Percutaneous Transluminal Angioplasty |
| 2 | Experimental | Test Arm: Experimental
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease. Receives: Device: LifeStent NT™ Self-Expanding Peripheral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.
Measured: 30 Day, 6 Month, and 12 Month
Secondary outcomes (1)
Safety: Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel at 30-days post-procedure. Freedom from 30-day death and 6-month
Measured: 30 Day, 6 Month and12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startJul 2004
- Primary completionAug 2006
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by C. R. BardThe 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
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor
- Investigators
- Barry T Katzen, MD, Principal investigator, Baptist Cardiac & Vascular Institute, Miami, FLJohn R Laird, MD, Principal investigator, Vascular Center at the University of California, Davis Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673985
- Sponsor's protocol ID
- 2003-12
- Acronym
- RESILIENT
- Status last verified
- Jul 2017
- First submitted
- 14 Feb 2008
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Cao AY, Jaff MR; RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012 Feb;19(1):1-9. doi: 10.1583/11-3627.1.
PubMed 22313193Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
PubMed 20484101
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter
- ClinicalTrials.gov ID
- NCT00673985
- Acronym / sponsor ID
- RESILIENT / 2003-12
- Keywords
- SFA, Edwards, Popliteal, LifeStent, PTA, Nitinol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Jul 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 May 2008 (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.
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone
Detailed description
The RESILIENT Trial is a dual stage clinical investigation designed to evaluate the safety and effectiveness of the Edwards Lifesciences self-expanding stent system.
Phase 1 consists of a prospective, multi-center, non-randomized study with a peri-procedure endpoint. Phase 2 consists of a prospective, multi-center, randomized study with a 30-day primary safety endpoint and a 6-month primary effectiveness endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Percutaneous Transluminal AngioplastyPTA Only: Active Comparator Percutaneous transluminal angioplasty (PTA) alone |
| 2 | Experimental | Device: LifeStent NT™ Self-Expanding Peripheral StentTest Arm: Experimental The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent approved by the IRB.
- ≥ 18 years old.
- Lifestyle-limiting claudication defined as: Rutherford Cat. 1-3.
- Target lesion(s) is de-novo or restenotic and located within the native SFA and/or proximal popliteal artery
- Angiographic evidence of ≥ 50% stenosis or occlusion
Key exclusion criteria (21 listed)
- Unable to conform to the study protocol procedures and visits.
- Lifestyle-limiting claudication/CLI (Rutherford Cat. 4-6)
- Patients who are pregnant or planning to become pregnant during the clinical investigation
- Contraindication to study related medications, Ni, Ti, Ta, or other media that is not amenable to pretreatment.
- History of bleeding diatheses or coagulopathy.
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 |
|---|---|---|
| Percutaneous Transluminal AngioplastyBalloon Angioplasty | Other | 1 |
| LifeStent NT™ Self-Expanding Peripheral StentBalloon angioplasty plus stent | Device | 2 |
Primary outcome
Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.
Time frame: 30 Day, 6 Month, and 12 Month
1 secondary outcome
Safety: Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel at 30-days post-procedure. Freedom from 30-day death and 6-month
Time frame: 30 Day, 6 Month and12 Month
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 14 Jul 2017.
- Derived from this study: PubMed 22313193Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Cao AY, Jaff MR; RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012 Feb;19(1):1-9. doi: 10.1583/11-3627.1.
- Derived from this study: PubMed 20484101Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
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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.
Barry T Katzen, MD principal investigator
Baptist Cardiac & Vascular Institute, Miami, FL
John R Laird, MD principal investigator
Vascular Center at the University of California, Davis Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Transluminal Angioplasty and LifeStent NT™ Self-Expanding Peripheral Stent in people with Intermittent Claudication and Atherosclerotic Disease, run by C. R. Bard.
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 8 inclusion and 21 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 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. (time frame: 30 Day, 6 Month, and 12 Month). 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 NCT00673985, which also lists 2 linked publications.
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 14 Jul 2017.