Acrobat Coronary Stent System Effectiveness European Study — ACES  

Coronary Artery Disease Clinical Trial

Official title: Acrobat Coronary Stent System Effectiveness European Study (European Multicenter Effectiveness Randomized Study of Svelte Medical Systems Acrobat Stent on a Wire Compared to Other BMS PCI in de Novo Coronary Lesions) ACES Trial

Status Terminated

Clinical Trial Summary

The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit and impact on resource utilization of percutaneous coronary interventions (PCI) with the Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS) implantable via direct stenting or after lesion pre-dilation, in patients with coronary lesions that are eligible for direct stenting and who are recruited and treated so as to reflect real-life routine practice.

Clinical Trial Description

The main objectives of this study are to test the following hypotheses:

1. The evaluated stent is clinically non-inferior to control BMS in terms of freedom of MACE

2. The evaluated stent is clinically beneficial compared to control BMS by reducing exposure to radiations, amount of contrast medium administered, procedure time, as well as amount of administered heparin,

3. The evaluated stent does not result in more frequent adverse events than control BMS,

4. The evaluated stent improves direct stenting success while not decreasing procedural success compared to control BMS.

5. Resource utilization (R.U.):

1. Hospital-perspective resource utilization during the index admission and index procedure is not greater with evaluated the stent and potentially lower than with control BMS

2. Resource utilization over a 6-month time-horizon, in relation to routine follow-up and MACE, is not greater with the evaluated stent than with control BMS. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT01761591
• Study type: Interventional
• Source: Svelte Medical Systems Europe
• Status: Terminated
• Phase: N/A
• Start date: December 2012
• Completion date: January 2014