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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232778
• Other study ID #: P00-5501
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 3, 2005
• Last updated: April 17, 2008
• Start date: May 2000
• Est. completion date: June 2006

Study information

• Verified date: April 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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%.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• GAMMA-Iridium-192 catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary effectiveness parameters will be late thrombosis of the target lesion at
Primary	9 months for non-stented patients and late thrombosis of the target lesion at
Primary	15 months for stented patients.
Primary	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.