Peripheral Vascular DiseasesDURABILITY IINCT00530712
Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis
A study testing PROTÉGÉ® EverFlex™ Self-Expanding Stent System in people with Peripheral Vascular Diseases and Claudication, run by Medtronic Endovascular.
Trial summary
This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Claudication
- What is being tested?
- PROTÉGÉ® EverFlex™ Self-Expanding Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jul 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.
- Symptomatic femoral-popliteal atherosclerosis.
- Willing to comply with all follow-up evaluations at the specified times.
- Provides written informed consent prior to enrollment in the study.
Who cannot join
- Previously implanted stent(s) or stent graft(s) in the target vessel.
- Planned use of devices other than angioplasty balloons during procedure.
- Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
- Life expectancy of less than 12 months.
- Symptomatic femoral disease in the opposite limb.
About this study
Official title: The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II
This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.
- Conditions
- Peripheral Vascular Diseases, Claudication
- Being tested
- PROTÉGÉ® EverFlex™ Self-Expanding Stent System
- Keywords
- SFA, Popliteal, Stent, EverFlex
- Medical subject headings
- Peripheral Vascular Diseases, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTÉGÉ® EverFlex™ Self-Expanding Stent SystemDevice
Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.
| Study group | Role | What they receive |
|---|---|---|
| PTA and Stenting with EverFlex device | Experimental | Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System Receives: Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency
Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.
Measured: 1 Year
Major Adverse Events
Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)
Measured: 30 Days
Secondary outcomes (12)
Single-Stent Primary Patency
Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.
Measured: 1 Year
Single-Stent Major Adverse Events
MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.
Measured: 30 Days
Major Adverse Events
MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.
Measured: 1 Year
Stent Fracture Rate
Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.
Measured: 1, 2 and 3 Years
Number of Participants With Decline in Rutherford Clinical Category
Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss.
Measured: 30 days
Improvement in Rutherford Clinical Category
Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.
Measured: 1 year
Increase in Ankle-Brachial Index From Baseline to 1 Year
Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.
Measured: 1 Year
Assisted Primary Patency
Assisted primary patency at 1 year was defined as PSV ratio < 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.
Measured: 1 Year
Secondary Patency
Secondary patency was defined as PSV ratio < 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.
Measured: 1 Year
Absolute Claudication Distance Improvement
Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.
Measured: 1 Year
Walking Improvement
Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline.
Measured: 1 Year
Duplex Ultrasound ≤ 2.4 Primary Patency
Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2012
- Study completionJul 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies 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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Matsumura, MD, Principal investigator, University of Wisconsin, MadisonKrishna Rocha-Singh, MD, Principal investigator, Prairie Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530712
- Sponsor's protocol ID
- P-2424
- Acronym
- DURABILITY II
- Status last verified
- Feb 2019
- First submitted
- 14 Sep 2007
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, Scheinert D, Rocha-Singh KJ. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013 Jul;58(1):73-83.e1. doi: 10.1016/j.jvs.2012.12.066. Epub 2013 May 2.
PubMed 23642924
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II
- ClinicalTrials.gov ID
- NCT00530712
- Acronym / sponsor ID
- DURABILITY II / P-2424
- Conditions
- Peripheral Vascular Diseases, Claudication
- Keywords
- SFA, Popliteal, Stent, EverFlex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Posted 15 Aug 2014
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 multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTA and Stenting with EverFlex device | Experimental | Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent SystemQualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.
- Symptomatic femoral-popliteal atherosclerosis.
- Willing to comply with all follow-up evaluations at the specified times.
- Provides written informed consent prior to enrollment in the study.
Key exclusion criteria (5 listed)
- Previously implanted stent(s) or stent graft(s) in the target vessel.
- Planned use of devices other than angioplasty balloons during procedure.
- Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
- Life expectancy of less than 12 months.
- Symptomatic femoral disease in the opposite limb.
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 |
|---|---|---|
| PROTÉGÉ® EverFlex™ Self-Expanding Stent SystemImplantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery. | Device | PTA and Stenting with EverFlex device |
Primary outcome
Primary Patency
Time frame: 1 Year
Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.
Major Adverse Events
Time frame: 30 Days
Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)
12 secondary outcomes
Single-Stent Primary Patency
Time frame: 1 Year
Single-Stent Major Adverse Events
Time frame: 30 Days
Major Adverse Events
Time frame: 1 Year
Stent Fracture Rate
Time frame: 1, 2 and 3 Years
Number of Participants With Decline in Rutherford Clinical Category
Time frame: 30 days
Improvement in Rutherford Clinical Category
Time frame: 1 year
Increase in Ankle-Brachial Index From Baseline to 1 Year
Time frame: 1 Year
Assisted Primary Patency
Time frame: 1 Year
Secondary Patency
Time frame: 1 Year
Absolute Claudication Distance Improvement
Time frame: 1 Year
Walking Improvement
Time frame: 1 Year
Duplex Ultrasound ≤ 2.4 Primary Patency
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23642924Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, Scheinert D, Rocha-Singh KJ. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013 Jul;58(1):73-83.e1. doi: 10.1016/j.jvs.2012.12.066. Epub 2013 May 2.
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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.
Jon Matsumura, MD principal investigator
University of Wisconsin, Madison
Krishna Rocha-Singh, MD principal investigator
Prairie Heart Institute
Questions about this trial
What is this clinical trial studying?
A study testing PROTÉGÉ® EverFlex™ Self-Expanding Stent System in people with Peripheral Vascular Diseases and Claudication, run by Medtronic Endovascular.
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 4 inclusion and 5 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 18 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2014). 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 Patency (time frame: 1 Year). 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 NCT00530712, 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 18 Feb 2019.