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

Study Overview
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Brief Summary
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The objectives of this study are: 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. 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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: GAMMA-Iridium-192 catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. 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. 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: Attempts to treat lesions in other vessels during the procedure were unsuccessful. The patient sustained a recent (<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB. Serum creatinine >2.0 mg/dl. The left ventricular ejection fraction is <40%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GAMMA-Iridium-192 catheter|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |