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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00232778
First received: October 3, 2005
Last updated: April 17, 2008
Last verified: April 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232778     History of Changes
Other Study ID Numbers: P00-5501
Study First Received: October 3, 2005
Last Updated: April 17, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014