NCT01651390

Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.

BIOLUX RCT - Clinical Performance of the Pantera LUX Paclitaxel Releasing Balloon Versus the Drug Eluting Orsiro Hybrid Stent System in Patients With In-stent Restenosis - a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine in a randomized controlled trial (RCT) whether percutaneous coronary intervention - in patients with in-stent restenosis in either bare metal stents or drug eluting stents - with the Pantera Lux balloon is angiographically non-inferior to percutaneous intervention with the Orsiro stent 6 months post-procedure.

Detailed description

This clinical investigation is an international, multi-center, randomized controlled trial with angiographic follow up at 6 months. Clinical follow ups will take place at 6, 12 and 18 months. Up to 210 subjects will be block randomized 2:1 to receive the Pantera Lux balloon or the Orsiro stent and will be stratified according to diabetic status at screening.

Conditions

• Coronary Artery Disease
• Coronary Restenosis

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention	Up to 140 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Pantera Lux drug coated balloon.
DEVICE	Percutaneous coronary intervention	Up to 70 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Orsiro drug eluting stent.

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-01-01
• Completion: 2016-07-01
• First posted: 2012-07-27
• Last updated: 2016-09-26

Locations

14 sites across 2 countries: Germany, Latvia