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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00232778
First Posted: October 5, 2005
Last Update Posted: April 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cordis Corporation
  Purpose

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.

Condition Intervention Phase
Coronary Artery Disease Device: GAMMA-Iridium-192 catheter Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)

Further study details as provided by Cordis Corporation:

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.

Estimated Enrollment: 579
Study Start Date: May 2000
Study Completion Date: June 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00232778     History of Changes
Other Study ID Numbers: P00-5501
First Submitted: October 3, 2005
First Posted: October 5, 2005
Last Update Posted: April 24, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases