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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00530712
First received: September 14, 2007
Last updated: July 31, 2012
Last verified: July 2012
  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 ]
  • Major Adverse Events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Single-Stent Primary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Single-Stent Major Adverse Events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Major Adverse Events [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  • Stent Fracture Rate [ Time Frame: 1, 2 and 3 Years ] [ Designated as safety issue: Yes ]
  • Decline in Rutherford Clinical Category [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Improvement in Rutherford Clinical Category [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Increase in ABI [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Assisted Primary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Secondary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Absolute Claudication Distance Improvement [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • 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 ]

Estimated Enrollment: 287
Study Start Date: August 2007
Estimated Study Completion Date: August 2014
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530712

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

No publications provided by Covidien

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00530712     History of Changes
Other Study ID Numbers: P-2424
Study First Received: September 14, 2007
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Covidien:
SFA
Popliteal
Stent
EverFlex

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

ClinicalTrials.gov processed this record on April 17, 2014