NCT00232778CompletedPhase 1
A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Cordis US Corp.
- Enrollment
- 579
- Primary Endpoint
- 15 months for stented patients.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%.
Outcomes
Primary Outcomes
15 months for stented patients.
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
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
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