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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: January 21, 2016
Last verified: January 2016

March 4, 2010
January 21, 2016
April 2010
March 2012   (final data collection date for primary outcome measure)
Major Adverse Cardiac Events (MACE) [ Time Frame: 6 M ] [ Designated as safety issue: Yes ]
Death, non-fatal MI, clinically driven target vessel revascularization (TVR)
Major Adverse Cardiac Events (MACE) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
MACE: defined as death, non-fatal MI, clinically driven TVR
Complete list of historical versions of study NCT01081366 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Drug Eluting Pantera Lux Catheter Registry
Evaluation of the Safety Profile of the Pantera Lux Paclitaxel Releasing Balloon for Coronary Arteries in Daily Clinical Practice
All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.

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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Coronary Artery Disease
Not Provided
Not Provided
Toelg R, Merkely B, Erglis A, Hoffman S, Bruno H, Kornowski R, Slagboom T, Naber C, Witzenbichler B, Graf K, Richardt G, Hehrlein C; DELUX investigators.. Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry. EuroIntervention. 2014 Sep;10(5):591-9. doi: 10.4244/EIJV10I5A102.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1064
May 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01081366
C0905 DELUX
Yes
No
Not Provided
Biotronik AG
Biotronik AG
Not Provided
Principal Investigator: Raph Toelg, MD Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany
Biotronik AG
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP