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

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.

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

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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