NCT01151033

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: KCRI · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Myocardial Ischemia

Interventions

Type	Name	Description
DEVICE	Drug Eluting Stent implantation	ProNOVA XR Drug Eluting Stent implantation

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-06-25
• Last updated: 2011-01-20

Locations

3 sites across 1 country: Poland