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Drug Eluting Pantera Lux Catheter Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081366
First Posted: March 5, 2010
Last Update Posted: January 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biotronik AG
  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

Further study details as provided by Biotronik AG:

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


Secondary Outcome Measures:
  • MACE [ Time Frame: 12 M ]
    Death, non-fatal MI, clinically driven TVR

  • All MACE [ Time Frame: 1, 6, and12 M ]
    Death, non-fatal MI, any revascularization

  • Clinically driven TVR [ Time Frame: 1, 6 and 12 M ]
  • Acute success [ Time Frame: Post procedure ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01081366     History of Changes
Other Study ID Numbers: C0905 DELUX
First Submitted: March 4, 2010
First Posted: March 5, 2010
Last Update Posted: January 22, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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