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

Primary Purpose

Peripheral Vascular Diseases, Claudication

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PROTÉGÉ® EverFlex™ Self-Expanding Stent System
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring SFA, Popliteal, Stent, EverFlex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PTA and Stenting with EverFlex device

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.
    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)

    Secondary Outcome Measures

    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.
    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.
    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.
    Stent Fracture Rate
    Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    September 14, 2007
    Last Updated
    February 14, 2019
    Sponsor
    Medtronic Endovascular
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00530712
    Brief Title
    Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis
    Acronym
    DURABILITY II
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medtronic Endovascular

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Vascular Diseases, Claudication
    Keywords
    SFA, Popliteal, Stent, EverFlex

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    287 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PTA and Stenting with EverFlex device
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    PROTÉGÉ® EverFlex™ Self-Expanding Stent System
    Intervention Description
    Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.
    Primary Outcome Measure Information:
    Title
    Primary Patency
    Description
    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.
    Time Frame
    1 Year
    Title
    Major Adverse Events
    Description
    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)
    Time Frame
    30 Days
    Secondary Outcome Measure Information:
    Title
    Single-Stent Primary Patency
    Description
    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.
    Time Frame
    1 Year
    Title
    Single-Stent Major Adverse Events
    Description
    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.
    Time Frame
    30 Days
    Title
    Major Adverse Events
    Description
    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.
    Time Frame
    1 Year
    Title
    Stent Fracture Rate
    Description
    Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.
    Time Frame
    1, 2 and 3 Years
    Title
    Number of Participants With Decline in Rutherford Clinical Category
    Description
    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.
    Time Frame
    30 days
    Title
    Improvement in Rutherford Clinical Category
    Description
    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.
    Time Frame
    1 year
    Title
    Increase in Ankle-Brachial Index From Baseline to 1 Year
    Description
    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.
    Time Frame
    1 Year
    Title
    Assisted Primary Patency
    Description
    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.
    Time Frame
    1 Year
    Title
    Secondary Patency
    Description
    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.
    Time Frame
    1 Year
    Title
    Absolute Claudication Distance Improvement
    Description
    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.
    Time Frame
    1 Year
    Title
    Walking Improvement
    Description
    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.
    Time Frame
    1 Year
    Title
    Duplex Ultrasound ≤ 2.4 Primary Patency
    Description
    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.
    Time Frame
    1 Year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jon Matsumura, MD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Krishna Rocha-Singh, MD
    Organizational Affiliation
    Prairie Heart Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23642924
    Citation
    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.
    Results Reference
    result

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    Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis

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