Drug Eluting Pantera Lux Catheter Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01081366
First received: March 4, 2010
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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


Condition
Coronary Artery Disease

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) [ Time Frame: 6 M ] [ Designated as safety issue: Yes ]
    Death, non-fatal MI, clinically driven target vessel revascularization (TVR)


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


Enrollment: 1064
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion criteria:

  • Signed Patient Informed Consent / Data Release Form
  • Patient eligible for percutaneous coronary intervention (PCI)
  • Patient is older than 18 years of age

Exclusion Criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations
Germany
Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Raph Toelg, MD Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01081366     History of Changes
Other Study ID Numbers: C0905 DELUX
Study First Received: March 4, 2010
Last Updated: March 19, 2013
Health Authority: Austria: Ethikkommission
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
Switzerland: Ethikkommission
United Kingdom: National Health Service

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014