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Drug Eluting Pantera Lux Catheter Registry

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ClinicalTrials.gov Identifier: NCT01081366
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Coronary Artery Disease

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.


Study Design

Study Type : Observational
Actual Enrollment : 1064 participants
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
Study Start Date : April 2010
Primary Completion Date : March 2012
Study Completion Date : May 2012
Groups and Cohorts


Outcome Measures

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


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

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

  3. Clinically driven TVR [ Time Frame: 1, 6 and 12 M ]
  4. Acute success [ Time Frame: Post procedure ]
    Clinical device success, clinical procedure success


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: March 5, 2010    Key Record Dates
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