Status:
COMPLETED
A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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%.
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
579 Patients enrolled
Trial Details
Trial ID
NCT00232778
Start Date
May 1 2000
End Date
June 1 2006
Last Update
April 24 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.