COBRA PzF Shield

Investigator: Alpesh Shah, MD

Study Coordinator:

Status: Open Not Enrolling Number: NCT01925794


Protocol Number: Pro00010696


This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and OUS. A minimum of 40% of total patients will be enrolled in the US. This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ? 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months and 1 year post index stenting procedure. Additional telephone follow-up for physical status, concomitant medication, and adverse events will occur at 720, 1080, 1440 and 1800 days post index procedure.
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