Drug Eluting Pantera Lux Catheter Registry

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01081366
• Lead Sponsor: Biotronik AG

Brief Summary

All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.

Detailed Description

All patients are treated with the Pantera Lux Paclitaxel releasing balloon.

Clinical follow ups at 1, 6 and 12 months after coronary intervention.

Study Timeline

• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Study Start: 2010-04
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1064

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	6 M	Death, non-fatal MI, clinically driven target vessel revascularization (TVR)

Secondary Outcome Measures

Name	Time	Method
MACE	12 M	Death, non-fatal MI, clinically driven TVR
All MACE	1, 6, and12 M	Death, non-fatal MI, any revascularization
Clinically driven TVR	1, 6 and 12 M
Acute success	Post procedure	Clinical device success, clinical procedure success

Trial Locations

Locations (1)

Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Germany