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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

579 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GAMMA-Iridium-192 catheter

Intervention Type DEVICE

Eligibility Criteria

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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%.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Other Identifiers

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P00-5501

Identifier Type: -

Identifier Source: org_study_id