Guidant enrolls first patient in carotid artery stenting study

By Elaine Rigoli

Tampa, Fla., March 17 - Guidant Corp. said the first patient has been enrolled in a new post-approval study of carotid artery stenting in high surgical risk patients, called Capture 2.

A key study objective is to gather additional and more extensive clinical data to extend Medicare coverage of carotid stenting to a broader group of patients, according to a company news release.

Guidant will include up to 10,000 patients at 400 U.S. centers.

Capture 2 was developed following Guidant's first post-approval study, Capture. 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 innovative electronic data capture system to collect the rate of death, stroke and myocardial infarction at 30 days following the procedure.

Guidant will work with Dartmouth Medical School and the Centers for Medicare and 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, according to the release.

Guidant develops treatments for cardiac and vascular disease. The company is based in Indianapolis, Ind.

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