SISR: A Multicenter Randomized Study of the Sirolimus-eluting Bx VELOCITY Balloon Expandable Stent vs. Intravascular Brachytherapy in the Treatment of Patients with In-Stent Restenotic coronary artery lesions
Study of:
Sirolimus-eluting Bx VELOCITY® stent; sponsored by Cordis, a Johnson and Johnson Company
Stents are small coil like tubes made of various types of metal materials. They are designed to keep blockages in the coronary arteries open. The drawback of stent placement is that a re-blockage (scar tissue) or restenosis can occur in 25% of the patients who receive a stent. There are various medical therapies to help prevent this from occurring. Currently, the treatment for restenosis is medications, radiation therapy, or coronary artery bypass surgery. We anticipate the FDA approval of drug eluding stents in the near future.
This study will evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular radiation therapy (Beta or Gamma) in the treatment of in-stent restenosis in native coronary arteries. The sirolimus-eluting stent was used in approximately 1200 patients with a new blockage in a native coronary artery. In this study, the Sirolimus-eluting Bx VELOCITY® stent will be used in a new way; to treat blockages (scar tissue) that form inside of a stent that has already been placed inside a coronary artery. Patients are followed at 30 days, 6, 9 months and yearly for 5 years post-procedure, with all patients undergoing repeat angiography at 6 months.
- M. Nicholas Burke, MD
- Ivan J. Chavez, MD, FACC
- Timothy D. Henry, MD, FACC
- John R. Lesser, MD, FACC
- Daniel Lips, MD, FACC
- James D. Madison, MD, FACC
- Michael R. Mooney, MD, FACC
- Anil K. Poulose, MD, FACC
- Jay H. Traverse, MD, FACC, FAHA
- Yale Wang, MD, FACC, FSCAI
For more information about the interventional cardiology research program at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Carol Stone at 612-863-9124.
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