Drug Eluting Pantera Lux Catheter Registry
All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.
Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of the Safety Profile of the Pantera Lux Paclitaxel Releasing Balloon for Coronary Arteries in Daily Clinical Practice|
- Major Adverse Cardiac Events (MACE) [ Time Frame: 6 M ] [ Designated as safety issue: Yes ]Death, non-fatal MI, clinically driven target vessel revascularization (TVR)
- MACE [ Time Frame: 12 M ] [ Designated as safety issue: Yes ]Death, non-fatal MI, clinically driven TVR
- All MACE [ Time Frame: 1, 6, and12 M ] [ Designated as safety issue: Yes ]Death, non-fatal MI, any revascularization
- Clinically driven TVR [ Time Frame: 1, 6 and 12 M ] [ Designated as safety issue: Yes ]
- Acute success [ Time Frame: Post procedure ] [ Designated as safety issue: No ]Clinical device success, clinical procedure success
|Study Start Date:||April 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
All patients are treated with the Pantera Lux Paclitaxel releasing balloon.
Clinical follow ups at 1, 6 and 12 months after coronary intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081366
|Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH|
|Bad Segeberg, Germany, 23795|
|Principal Investigator:||Raph Toelg, MD||Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany|