DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)
DEB-DRAGON
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).
1 other identifier
observational
1,369
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Shorter than P25 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 31, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedSeptember 21, 2021
September 1, 2021
3 months
May 31, 2020
September 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
TLR
target lesion revascularisation
3 years
Secondary Outcomes (5)
DOCE
3 years
TVR
3 years
TV-MI
3 years
cardiac death
3 years
myocardial infarction
3 years
Study Arms (2)
ISR PCI with thin-DES
ISR PCI with DEB
Interventions
Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)
Eligibility Criteria
Patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES
You may qualify if:
- All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Silesialead
- Wojciech Wojakowskicollaborator
Study Sites (9)
Department of Invasive Cardiology, Medical University of Bialystok
Bialystok, 15-089, Poland
Cardiovascular Institute, Nicolaus Copernicus University, Bydgoszcz, Poland
Bydgoszcz, Poland
First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
Gdansk, Poland
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, 40-635, Poland
Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
Krakow, Poland
Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
Warsaw, Poland
Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
Warsaw, Poland
Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
Wroclaw, Poland
Third Department of Cardiology, Medical University of Katowice
Zabrze, Poland
Related Publications (2)
De Filippo O, Wanha W, Sanavia T, Januszek R, Giacobbe F, Campo G, Pinxterhuis TH, Capodanno D, Tomasiewicz B, Iannaccone M, Leone A, Wolny R, Bruno F, Patti G, Musumeci G, Liccardo G, Verardi R, Roubin SR, Tarantini G, Kuzma L, Perl L, Gagnor A, Reczuch K, Conrotto F, Tuttolomondo D, Ploumen EH, Niezgoda P, Caglioni S, Omede P, Greco A, Kubica J, Gil RJ, Piccolo R, Kornowski R, Bil J, Morena A, Zocca P, Pennone M, Gasior M, Jaguszewski M, von Birgelen C, Fariselli P, De Ferrari GM, Wojakowski W, D'Ascenzo F. Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry. EuroIntervention. 2024 Nov 4;20(21):e1340-e1354. doi: 10.4244/EIJ-D-24-00491.
PMID: 39492702DERIVEDWanha W, Bil J, Januszek R, Gilis-Malinowska N, Figatowski T, Milewski M, Pawlik A, Staszczak B, Wybraniec M, Tomasiewicz B, Kubler P, Kuliczkowski W, Walczak T, Hrymniak B, Desperak P, Mielczarek M, Ciecwierz D, Niezgoda P, Wolny R, Chudzik M, Kuzma L, Kralisz P, Kedhi E, D'Ascenzo F, Hudziak D, Kowalowka A, Smolka G, Reczuch K, Gruchala M, Kubica J, Gil RJ, Dobrzycki S, Dudek D, Bartus S, Gasior M, Ochala A, Witkowski A, Jaguszewski M, Wojakowski W. Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry). Circ Cardiovasc Interv. 2021 Sep;14(9):e010868. doi: 10.1161/CIRCINTERVENTIONS.121.010868. Epub 2021 Sep 3.
PMID: 34474584DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 31, 2020
First Posted
June 4, 2020
Study Start
October 10, 2019
Primary Completion
December 30, 2019
Study Completion
March 1, 2020
Last Updated
September 21, 2021
Record last verified: 2021-09