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

NCT00232778 | Completed Phase 1

• 1 other identifier: P00-5501
• Study Type: interventional
• Target: 579
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of this study are:

1. 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. 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

• 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.

Interventions

GAMMA-Iridium-192 catheter DEVICE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients age must be \>18 years and \<85 years.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Cordis US Corp.: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: May 1, 2000
• Study Completion: June 1, 2006
• Last Updated: April 24, 2008

Record last verified: 2008-04