NCT01930903

PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon

Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Biotronik France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.

Conditions

• Coronary Artery Disease
• High Bleeding Risk Patients

Interventions

Type	Name	Description
DEVICE	Pantera Lux Drug Eluting Balloon	All patients are treated with the PRO-Kinetic Energy Stent and Pantera Lux drug eluting balloon for the last post dilatation.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-08-29
• Last updated: 2015-04-30

Locations

1 site across 1 country: France