A Medical Device Daily
Guidant (Indianapolis) reported progress in two trials recently, one related to its continued push to get a drug-eluting stent approved for use in the treatment of coronary artery disease (CAD) and the other to enhanced Medicare reimbursement of carotid stenting.
The company said it has completed enrollment of 1,002 patients in the randomized U.S. portion of its SPIRIT III drug-eluting stent pivotal trial.
The randomized U.S. cohort will support the company's premarket approval submission to the FDA for the Xience V everolimus-eluting coronary stent system for the treatment of CAD.
SPIRIT III is an international clinical trial consisting of a 1,002-patient prospective, randomized, single-blind U.S. cohort evaluating the safety and efficacy of the Xience V system compared to Boston Scientific 's (Natick, Massachusetts) Taxus Express2 paclitaxel-eluting coronary stent system, and four non-randomized trial arms.
The trial is being conducted in the U.S. and Japan. Xience V, which uses Guidant's Multi-Link Vision cobalt chromium stent platform, received CE-mark approval in January and will be launched in Europe in 2Q06.
Gregg Stone, MD, professor of medicine and director of cardiovascular research and education of Columbia University Medical Center (New York), and Campbell Rogers, MD, director of cardiac catheterization at Brigham and Women's Hospital (Boston), are co-principal investigators of the study. Shigeru Saito, MD, director of cardiology and catheterization laboratories, Shonan Kamakura Hospital , is the principal investigator for the Japan arm of the trial.
The company also reported the enrollment of the first patient in a new post-approval study of carotid artery stenting in high-surgical-risk patients, called CAPTURE 2 (Carotid Acculink/Accunet Post-Approval Trial to Uncover Rare Events).
A key objective of the 10,000-patient CAPTURE 2 is to gather additional and more extensive clinical data to extend Medicare coverage of carotid stenting to a broader group of patients.
The Guidant-sponsored study uses the company's FDA-approved RX Acculink carotid stent system and RX Accunet embolic protection system, which are indicated for high surgical risk patients. CAPTURE 2 will include about 400 U.S. centers.
CAPTURE 2 was developed following Guidant's first post-approval study, CAPTURE. The company said that data from CAPTURE 2 will provide a “deeper and broader understanding“ of carotid stenting in real-world clinical settings with physicians who enter Guidant's training program with varying levels of experience, and will examine outcomes in both symptomatic and asymptomatic patients.
The study will use an electronic data capture system to collect the rate of death, stroke and myocardial infarction at 30 days following the procedure.
The company will work with Dartmouth Medical School (Hanover, New Hampshire) and the Centers for Medicare & Medicaid Services to potentially link to the Medicare database to collect one-year patient outcomes.
An executive committee made up of physicians from multiple specialties will oversee the trial.