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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 23, 2013