Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title: The Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease

Status Active, not recruiting

Clinical Trial Summary

To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable Coronary Stent System for the treatment of de novo and restenotic (previously unstented) lesions in native coronary arteries in subjects with coronary artery disease (CAD) having a reference vessel diameter (RVD) between 2.5 - 4.0 mm and a lesion length ≤ 26 mm amenable to percutaneous coronary intervention (PCI) with a single stent in subjects with symptomatic ischemic heart disease.

Clinical Trial Description

Safety and Efficacy will be demonstrated by the rate of Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days of the post-stent placement procedure.

Additionally, Major Adverse Cardiac Events (MACE)at 30, 180 and 270 days defined as a composite of all-cause death, myocardial infarction (MI) (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)]will be documented. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT00744107
• Study type: Interventional
• Source: Medlogics Device Corporation
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 2008
• Completion date: September 2010