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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

GAMMA-Iridium-192 catheter

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00232778

First Posted

October 3, 2005

Last Updated

April 17, 2008

Sponsor

Cordis Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00232778

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

May 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cordis Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

579 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

GAMMA-Iridium-192 catheter

Primary Outcome Measure Information:

Title

The primary effectiveness parameters will be late thrombosis of the target lesion at

Title

9 months for non-stented patients and late thrombosis of the target lesion at

Title

15 months for stented patients.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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%.

Coronary Artery Disease

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial