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

Completed

• Conditions: In Stent Restenosis
• Interventions: Device: percutaneous coronary intervention

• Registration Number: NCT04415216
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Primary Completion: 2019-12-30
• Study Completion: 2020-03-01
• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-05-31
• Study First Posted: 2020-06-04
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 1369

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ISR PCI with thin-DES	percutaneous coronary intervention	-
ISR PCI with DEB	percutaneous coronary intervention	-

Primary Outcome Measures

Name	Time	Method
TLR	3 years	target lesion revascularisation

Secondary Outcome Measures

Name	Time	Method
cardiac death	3 years
DOCE	3 years	composite of cardiac death, TLR, and target vessel MI
myocardial infarction	3 years
TVR	3 years	target vessel revascularization
TV-MI	3 years	target vessel myocardial infarction

Trial Locations

Locations (9)

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland; 🇵🇱 Katowice, Poland

Department of Invasive Cardiology, Medical University of Bialystok; 🇵🇱 Białystok, Poland

Cardiovascular Institute, Nicolaus Copernicus University, Bydgoszcz, Poland; 🇵🇱 Bydgoszcz, Poland

Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University; 🇵🇱 Wrocław, Poland

Third Department of Cardiology, Medical University of Katowice; 🇵🇱 Zabrze, Poland

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland; 🇵🇱 Gdańsk, Poland

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland; 🇵🇱 Kraków, 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; 🇵🇱 Warszawa, Poland