Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty

PHASE4CompletedINTERVENTIONAL
Enrollment

597

Participants

Timeline

Start Date

January 11, 2012

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Saphenous Vein Graft Atherosclerosis
Interventions
DEVICE

Bare Metal Stent

Patients receive one or more bare metal stents in the saphenous vein graft target lesion.

DEVICE

Drug-Eluting Stent

Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.

DRUG

Blinded clopidogrel

For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.

DRUG

Placebo

For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.

DRUG

Thienopyridine (open-label)

For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Trial Locations (25)

10010

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY, New York

20422

Washington DC VA Medical Center, Washington, DC, Washington D.C.

27705

Durham VA Medical Center, Durham, NC, Durham

28805

Asheville VA Medical Center, Asheville, NC, Asheville

30033

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur

32608

North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville

38104

Memphis VA Medical Center, Memphis, TN, Memphis

40502

Lexington VA Medical Center, Lexington, KY, Lexington

44106

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland

48105

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor

55417

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis

63106

St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis

70112

Southeast Louisiana Veterans Health Care System, New Orleans, LA, New Orleans

73104

Oklahoma City VA Medical Center, Oklahoma City, OK, Oklahoma City

75216

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas

77030

Michael E. DeBakey VA Medical Center, Houston, TX, Houston

80220

VA Eastern Colorado Health Care System, Denver, CO, Denver

85723

Southern Arizona VA Health Care System, Tucson, AZ, Tucson

94121

San Francisco VA Medical Center, San Francisco, CA, San Francisco

98108

VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle

72205-5484

Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR, Little Rock

60141-5000

Edward Hines Jr. VA Hospital, Hines, IL, Hines

46202-2884

Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis

02132

VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA, West Roxbury

65201-5297

Harry S. Truman Memorial, Columbia, MO, Columbia

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT01121224 - Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty | Biotech Hunter | Biotech Hunter