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Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (DURABILITY II)

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ClinicalTrials.gov Identifier: NCT00530712
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : August 15, 2014
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Claudication Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2007
Actual Primary Completion Date : March 2012
Actual Study Completion Date : July 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: PTA and Stenting with EverFlex device
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
 Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System
Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. Single-Stent Primary Patency [ Time Frame: 1 Year ]
    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.

  2. Single-Stent Major Adverse Events [ Time Frame: 30 Days ]
    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.

  3. Major Adverse Events [ Time Frame: 1 Year ]
    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.

  4. Stent Fracture Rate [ Time Frame: 1, 2 and 3 Years ]
    Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.

  5. Number of Participants With Decline in Rutherford Clinical Category [ Time Frame: 30 days ]
    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.

  6. Improvement in Rutherford Clinical Category [ Time Frame: 1 year ]
    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.

  7. Increase in Ankle-Brachial Index From Baseline to 1 Year [ Time Frame: 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.

  8. Assisted Primary Patency [ Time Frame: 1 Year ]
    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.

  9. Secondary Patency [ Time Frame: 1 Year ]
    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.

  10. Absolute Claudication Distance Improvement [ Time Frame: 1 Year ]
    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.

  11. Walking Improvement [ Time Frame: 1 Year ]
    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.

  12. Duplex Ultrasound ≤ 2.4 Primary Patency [ Time Frame: 1 Year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530712


Sponsors and Collaborators
Medtronic Endovascular
Investigators
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Principal Investigator: Jon Matsumura, MD University of Wisconsin, Madison
Principal Investigator: Krishna Rocha-Singh, MD Prairie Heart Institute
More Information
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Publications of Results:

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00530712     History of Changes
Other Study ID Numbers: P-2424
First Posted: September 17, 2007    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: February 18, 2019
Last Verified: February 2019
Keywords provided by Medtronic Endovascular:
SFA
Popliteal
Stent
EverFlex
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Atherosclerosis