- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01081366
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
Conditions
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- C0905 DELUX
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.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina