NCT00961181

Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis A Prospective, Multi-centre, Non-randomized Clinical Trial With Follow-up Investigations at 1, 6 and 12 Months

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.

Detailed description

All patients are treated with the paclitaxel releasing balloon Pantera Lux. The indication is in-stent restenosis in either bare metal stent (BMS) or drug eluting stent (DES). Clinical follow up visits at 1, 6 and 12 months. Angiographic follow up visit at 6 months.

Conditions

• In-stent Coronary Artery Restenosis

Interventions

Type	Name	Description
DEVICE	Paclitaxel Releasing Balloon	Percutaneous coronary intervention with paclitaxel releasing balloon

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-12-01
• Completion: 2011-05-01
• First posted: 2009-08-18
• Last updated: 2013-05-06
• Results posted: 2013-05-03

Locations

1 site across 1 country: Germany