Gamma V Localized Radiation Therapy to Inhibit Restenosis - GAMMA V

May 16, 2002
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Date Updated:
05/16/2002
Original Posted Date:
05/16/2002

Description:

To determine whether longer term anti-platelet therapy (12 months for newly stented, 6 months for non-stented) after gamma-brachytherapy will reduce the late thrombosis rate

Hypothesis:

Gamma brachytherapy has been shown to be associated with higher rates of late stent thrombosis, all of which occurred after anti-platelet therapy was stopped. Longer term antiplatelet therapy may reduce this risk

Study Design

Study Design:

Patients Enrolled: 600
Mean Follow Up: 12 months

Patient Populations:

>60% in-stent restenosis of a native coronary Ischemia related to target lesion Lesion diameter 2.75-4.0 mm Lesion length <45 mm Successful intervention with <30% residual stenosis Use of non-coil stents

Primary Endpoints:

MACE at 12 months

Secondary Endpoints:

Angiographic restenosis at 12 months

Drug/Procedures Used:

Antiplatelet therapy (usually ASA and clopidigrel) was given for 6 months in patients without a new stent and for 12 month for patients with a new stent after gamma brachytherapy

Keywords: Platelet Aggregation Inhibitors, Coronary Restenosis, Thrombosis, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Brachytherapy, Stents


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