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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00530712
First received: September 14, 2007
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Peripheral Vascular Diseases
Claudication
Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Primary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1, 2 and 3 Years ] [ Designated as safety issue: Yes ]
    Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. only 1 year data presented here.

  • Decline in Rutherford Clinical Category [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Defined as an increase of one or more categories in RCC compared to baseline.

  • Improvement in Rutherford Clinical Category [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Duplex Ultrasound ≤ 2.4 Primary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Enrollment: 287
Study Start Date: August 2007
Study Completion Date: July 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530712

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

Publications:
Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00530712     History of Changes
Other Study ID Numbers: P-2424
Study First Received: September 14, 2007
Results First Received: July 28, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Covidien:
SFA
Popliteal
Stent
EverFlex

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Menthol
Antipruritics
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014