DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry) (DEB-DRAGON)

September 18, 2021 updated by: Wojciech Wańha, Medical University of Silesia

Long-term Outcomes Following Drug Eluting Balloon Versus Thin Struts Drug Eluting Stents for Treating In-stent Restenosis: Propensity Score-matched Analysis(DEB-Dragon Registry).

Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1369

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

  • Poland
      • Białystok, Poland, 15-089
        • Department of Invasive Cardiology, Medical University of Bialystok
      • Bydgoszcz, Poland
        • Cardiovascular Institute, Nicolaus Copernicus University, Bydgoszcz, Poland
      • Gdańsk, Poland
        • First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
      • 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
      • 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
      • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES

Description

Inclusion Criteria:

• All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES.

Exclusion Criteria:

  • PCI with DES struts thickness >100μm
  • PCI with DEB and thin-DES in the same procedure
  • PCI of other vascular territories during the same procedure
  • PCI in saphenous vain graft or internal mammary artery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ISR PCI with thin-DES
Device: percutaneous coronary intervention
Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)
ISR PCI with DEB
Device: percutaneous coronary intervention
Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TLR
Time Frame: 3 years
target lesion revascularisation
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial infarction
Time Frame: 3 years
3 years
DOCE
Time Frame: 3 years
composite of cardiac death, TLR, and target vessel MI
3 years
TVR
Time Frame: 3 years
target vessel revascularization
3 years
TV-MI
Time Frame: 3 years
target vessel myocardial infarction
3 years
cardiac death
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Medical University of Silesia

Collaborators

Wojciech Wojakowski

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.

General Publications

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)

October 10, 2019

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

May 31, 2020

First Submitted That Met QC Criteria

May 31, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 02

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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