Clinical trial NCT00205790: GORE-TEX PROPATEN Vascular Graft Study
Official title: Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Diseases
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary patency at 12 months
measure: Major device complication rates at 12 months
Secondary outcomes:
measure: Technical failures
measure: Secondary patency
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Upper Chesapeake Medical Center
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Mercy Medical Center
state: Massachusetts
city: Bingham Farms
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Hospital
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Plains
country: United States
facility: Wilkes-Barre General Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist East Hospital
state: Tennessee
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
Study officials:
affiliation: Maimonides Hospital, Brooklyn NY
name: Enrico Ascher, MD
role: PRINCIPAL_INVESTIGATOR
References: