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Completed

NCT Number: NCT00232778

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

GAMMA-Iridium-192 catheter

Device

Primary outcomes

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

  2. 9 months for non-stented patients and late thrombosis of the target lesion at

  3. 15 months for stented patients.

  4. 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.

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Important dates

Study start
2000
Study completion
2006
First posted
Oct 5, 2005
Registry last updated
Apr 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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