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GORE-TEX PROPATEN Vascular Graft Study

This study has been completed.
Sponsor:
Information provided by:
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00205790
First received: September 12, 2005
Last updated: August 6, 2008
Last verified: August 2008

September 12, 2005
August 6, 2008
February 2003
Not Provided
  • Primary patency at 12 months
  • Major device complication rates at 12 months
Same as current
Complete list of historical versions of study NCT00205790 on ClinicalTrials.gov Archive Site
  • Technical failures
  • Secondary patency
Same as current
Not Provided
Not Provided
 
GORE-TEX PROPATEN Vascular Graft Study
Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts

To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Peripheral Vascular Diseases
Device: Vascular graft
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2007
Not Provided

Inclusion Criteria:

  • Patient requires primary above-knee bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery proximal to the medial head of the gastrocnemius;
  • Patient has Grade III or IV occlusive vascular disease;
  • Patient has a postoperative life expectancy greater than one year;
  • Patient is at least 21 years of age;
  • Patient is able to comply with all study requirements and be available for follow-up visits at 1 month, 6 months and 12 months post procedure;
  • Patient is willing and able to provide written, informed consent.

Exclusion Criteria:

  • Patient had a previous bypass in the diseased extremity (below iliacs);
  • Patient has known coagulation disorders including hypercoagulability;
  • Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin;
  • Patient has an acute embolic arterial occlusion;
  • Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
  • Patient had percutaneous transluminal angioplasty to the implant site within the previous 30 days;
  • Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure;
  • Patient has active infection in the region of graft placement; or
  • Patient has an incomplete preoperative assessment (as outlined in this protocol) due to an emergency procedure, a traumatic injury or any other reason.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205790
PPT-01-04
Not Provided
Not Provided
W.L.Gore & Associates
Not Provided
Principal Investigator: Enrico Ascher, MD Maimonides Hospital, Brooklyn NY
W.L.Gore & Associates
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP