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

Cordis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Coronary Artery Disease

Treatments: Device: GAMMA-Iridium-192 catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00232778

P00-5501

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)