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Status:

COMPLETED

GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

Lead Sponsor:

W.L.Gore & Associates

Conditions:

Peripheral Vascular Diseases

Eligibility:

All Genders

21+ years

Phase:

PHASE4

Brief Summary

To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.

Detailed Description

This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized i...

Eligibility Criteria

Inclusion

  • Lifestyle-limiting claudication or rest pain.
  • Subject (or their legal guardian) has read, understood and provided written informed consent.
  • At least 21 years of age.
  • Quality of life questionnaires completed.
  • Noninvasive lower extremity arterial studies within 45-days prior to study procedure.
  • If applicable, staged ipsilateral vascular procedure ≥ 14-days prior to study procedure.
  • If applicable, vascular treatment on non-study leg for bilateral claudication ≥ 14-days prior to study procedure.
  • Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test.
  • Projected life expectancy of greater than three years.
  • The ability to comply with protocol.
  • Angiographic and Lesion Requirements meets protocol criteria.

Exclusion

  • Untreated flow-limiting aortoiliac occlusive disease.
  • Any previous stenting or surgery in the target vessel.
  • Subjects with arterial lesions requiring treatment with device diameters other than 6, 7, or 8 mm.
  • Severe ipsilateral common femoral/profunda disease requiring surgical intervention.
  • Femoral or popliteal aneurysm.
  • Non-atherosclerotic disease resulting in occlusion.
  • Tibial artery disease requiring treatment.
  • Prior ipsilateral femoral artery bypass.
  • Severe medical comorbidities.
  • Popliteal artery vascular access at any time during procedure.
  • Antegrade and retrograde vascular access on the same common femoral artery at the time of the SFA intervention.
  • Serum creatinine \> 2.5 mg/dL within 45 days prior to study procedure.
  • Major distal amputation.
  • Septicemia.
  • Any previously known coagulation disorder.
  • Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion).
  • Contraindication to anticoagulation or antiplatelet therapy.
  • Known allergies to stent/stent-graft components.
  • History of prior life-threatening reaction to contrast agent.
  • Currently participating in another clinical research trial.
  • Current peritoneal or hemodialysis.

Key Trial Info

Start Date :

September 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2011

Estimated Enrollment :

148 Patients enrolled

Trial Details

Trial ID

NCT00228384

Start Date

September 1 2005

End Date

January 1 2011

Last Update

June 4 2012

Active Locations (15)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (15 locations)

1

Mayo Clinic Phoenix

Phoenix, Arizona, United States, 85054

2

Arkansas Heart

Little Rock, Arkansas, United States, 72211

3

Holy Cross Hospital

Fort Lauderdale, Florida, United States, 33308

4

Vascular Surgical Associate

Austell, Georgia, United States, 30106