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A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System — EURONOVA  

Myocardial Ischemia Clinical Trial

Official title:
A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

Clinical Trial Summary

The objective of this study is the assessment of the performance, safety and efficacy of the ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo native coronary artery lesions.

Clinical Trial Description

This study is a prospective, single arm, multicenter registry of approximately 50 patients undergoing PCI with the ProNOVA Drug Eluting Coronary Stent System according to its Instructions for Use.

The purpose of this registry is the evaluation of the performance, safety and efficacy of ProNOVA XR DES in real-world patients. Following initial stent implantation, all patients will have clinical follow up at 30 days, at 6 and 12 months. Additionally all patients will have a angiographic F/U at 6 months to assess the late luminal loss by QCA measurements and the neointimal volume including stent apposition by intravascular ultrasound. ;

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

Clinical Trial Details
NCT number NCT01151033
Study type Interventional
Source KCRI
Contact
Status Completed
Phase Phase 2/Phase 3
Start date November 2008
Completion date September 2010
View Details
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