A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)

Cordis US Corp.579 enrolled

Overview

The objectives of this study are: 1. To show a reduction in the late thrombosis (LT) rate following percutaneous revascularization using current interventional techniques with new stent placement and intravascular radiation therapy (IRT) with a long-term antiplatelet regimen (12 months) compared to the stented patients on short-term antiplatelet regimen (2 months) from the IRT arm of GAMMA I Trial. 2. To show equivalence in the LT rate following percutaneous revascularization using current interventional techniques without new stent placement and IRT with a long-term antiplatelet regimen (6 months) compared to non-stented patients on short term antiplatelet therapy (2 months or less) from a pooling of the IRT arms of the GAMMA I, SCRIPPS, and WRIST Trials.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

579

Conditions

Coronary Artery Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The patient has a restenosis of \>60% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement. 2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. 3. The study target lesion must be located in a restenotic native coronary artery measuring \>2.75 and \<4.0 mm in diameter and 45 mm in length. The target lesion must have undergone coronary interventional treatment \>4 weeks previously. 4. The vessel 1 cm distal to the target lesion is \>2.5 mm in diameter. 5 Patients age must be \>18 years and \<85 years. Exclusion Criteria: 1. Attempts to treat lesions in other vessels during the procedure were unsuccessful. 2. The patient sustained a recent (\<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB. 3. Serum creatinine \>2.0 mg/dl. 4. The left ventricular ejection fraction is \<40%.

Outcomes

Primary Outcomes

The primary effectiveness parameters will be late thrombosis of the target lesion at

9 months for non-stented patients and late thrombosis of the target lesion at

15 months for stented patients.

The safety criteria will include post-procedure Q-wave myocardial infarction, non-Q-wave myocardial infarction, death, need for bypass surgery, need for emergency bypass surgery,or need for repeat coronary angioplasty.