Sponsor Name

MedAlliance

Brief summary

A Prospective Randomized (1:1), Multi-center, International, Open label Clinical trial. The objective is to demonstrate non-inferiority for Target Vessel Failure (TVF) of a treatment strategy with first line SELUTION SLR Drug Eluting Balloon (DEB) plus provisional Drug Eluting Stent (DES) vs. systematic treatment with DES for the treatment of de novo coronary lesions, at 1 year and 5 years.

Primary endpoints

1. Target Vessel Failure (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-Target Vessel Revascularization)) at 1 year
2. Target Vessel Failure at 5 years

CERC Services

Regulatory submissions, Project management, Monitoring management, Data management; Core Laboratory, Safety activities; Statistical activities, CEC and DSMB activities; and Final Clinical Report

Countries

Up to 15 countries: Austria, Czech Republic, Finland, France, Germany, Italy, Poland, Singapore, Switzerland, UK

(pending confirmation for Malaysia, Spain, Taiwan, The Netherlands)

Number of investigational sites:

Up to 80 sites (41 activated sites, submissions ongoing)

Number of patients:

3326 patients