Drug Eluting Pantera Lux Catheter Registry
This study has been completed.
Information provided by (Responsible Party):
First received: March 4, 2010
Last updated: March 19, 2013
Last verified: March 2013
All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.
||Observational Model: Cohort
Time Perspective: Prospective
||Evaluation of the Safety Profile of the Pantera Lux Paclitaxel Releasing Balloon for Coronary Arteries in Daily Clinical Practice
Primary Outcome Measures:
Secondary Outcome Measures:
- 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:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
All comers registry. Patients treated with the Pantera Lux Paclitaxel releasing balloon catheter are enrolled consecutively to represent a typical set of patients at each site.
- Signed Patient Informed Consent / Data Release Form
- Patient eligible for percutaneous coronary intervention (PCI)
- Patient is older than 18 years of age
- Patient has a known allergy against appropriate anticoagulation / antiplatelet therapy
- Patients with known allergy against paclitaxel or BTHC
- Patients with a target lesion that was previously treated by brachytherapy
- Pregnant woman or lactating woman
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081366
|Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH
|Bad Segeberg, Germany, 23795 |
||Raph Toelg, MD
||Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 4, 2010
||March 19, 2013
Belgium: Ethics Committee
Canada: Ethics Review Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Israel: Ethics Commission
Latvia: Institutional Review Board
Netherlands: Independent Ethics Committee
Spain: Ethics Committee
United Kingdom: National Health Service
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Coronary Artery Disease
Arterial Occlusive Diseases