Drug Eluting Pantera Lux Catheter Registry

January 21, 2016 updated by: Biotronik AG

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

1064

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bad Segeberg, Germany, 23795
        • Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (MACE)
Time Frame: 6 M
Death, non-fatal MI, clinically driven target vessel revascularization (TVR)
6 M

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 12 M
Death, non-fatal MI, clinically driven TVR
12 M
All MACE
Time Frame: 1, 6, and12 M
Death, non-fatal MI, any revascularization
1, 6, and12 M
Clinically driven TVR
Time Frame: 1, 6 and 12 M
1, 6 and 12 M
Acute success
Time Frame: Post procedure
Clinical device success, clinical procedure success
Post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Raph Toelg, MD, Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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