- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05112250
IVL for Stent Underexpantsion (IVL-DRAGON)
November 5, 2021 updated by: Wojciech Wańha, Medical University of Silesia
Intravascular Lithotripsy for the Treatment of Stent Underexpansion: the Multicenter IVL-DRAGON Registry
The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers.
The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to <30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
62
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
-
-
-
Białystok, Poland
- Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
-
Gdańsk, Poland
- First Department of Cardiology, Medical University of Gdansk
-
Katowice, Poland, 40-635
- Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
-
Kraków, Poland
- Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
-
Lubin, Poland
- Miedziowe Centrum Zdrowia S.A.
-
Opole, Poland
- Department of Cardiology, University Hospital, Institute of Medical Sciences
-
Poznań, Poland
- Department of Cardiology, Poznan University of Medical Sciences
-
Poznań, Poland
- Department of Cardiology
-
Rzeszów, Poland
- Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow
-
Warsaw, Poland
- 1st Department of Cardiology, Medical University of Warsaw
-
Warsaw, Poland
- Department of Cardiology and Internal Diseases, Military Institute of Medicine
-
Warszawa, Poland
- Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
-
Warszawa, Poland
- Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
-
Wejherowo, Poland
- Department of Invasive Cardiology, Wejherowo
-
Wrocław, Poland
- Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
-
Zabrze, Poland
- Third Department of Cardiology, Medical University of Katowice
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
consecutive patients with stent underexpansion treated with intravascular lithotripsy (IVL)
Description
Inclusion Criteria:
- stent underexpansion treated with intravascular lithotripsy (IVL)
Exclusion Criteria:
- no
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: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Success
Time Frame: 30 days
|
Reduction of stent underexpansion to the value of <30% with no evidence of in-hospital device-oriented composite end point (DOCE)
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DOCE
Time Frame: 30 days
|
composite of cardiac death, target lesion revascularization (TLR), target lesion revascularization, (TLR), and target vessel myocardial infarction (MI)
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
November 1, 2019
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
October 19, 2021
First Submitted That Met QC Criteria
November 5, 2021
First Posted (Actual)
November 8, 2021
Study Record Updates
Last Update Posted (Actual)
November 8, 2021
Last Update Submitted That Met QC Criteria
November 5, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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