Medtronic initiates enrollment in peripheral arterial disease trial

Approved by the FDA under an investigational device exemption (IDE), the superficial femoral artery (SFA) study is a prospective, multicenter, single-arm trial planned to enroll 178 subjects at up to 30 sites globally. Enrolling patients with symptomatic peripheral arterial disease (PAD) in the SFA, the study has primary endpoints of major adverse events (MAE) and patency of the stent at 12 months.

The complete self-expanding (SE) stent is currently being evaluated in an IDE-approved clinical trial for use in the treatment of iliac artery lesions in subjects with symptomatic and asymptomatic PAD. The Complete SE Iliac Registry is a non-randomized, prospective study designed to enroll 60 subjects. The primary study endpoints are MAEs at 30 days and nine months. With 12 US sites participating, enrollment is nearly complete.

Similarly, the balloon-expandable Assurant Cobalt stent is currently being evaluated in an IDE-approved clinical trial as a treatment for iliac artery lesions in subjects with symptomatic PAD. Initiated in October 2008, the study is a non-randomized, prospective, single-arm trial with an enrollment target of 123 subjects at 20 US sites. The primary endpoint of the study is MAEs at nine months.

John Laird, principal investigator of the study, said: Medtronic’s clinical research program for peripheral arterial disease demonstrates a strong commitment to helping physicians and their patients. Through three clinical trials currently underway, Medtronic is partnering with physicians worldwide to evaluate the safety and efficacy of its stents in the treatment of PAD.