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

In Stent Restenosis Clinical Trial

— DEB-DRAGON  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415216
• Other study ID #: 02
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2021
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1369
• Est. completion date: March 1, 2020
• Est. primary completion date: December 30, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• In Stent Restenosis

Intervention

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)

Locations

Country	Name	City	State
Poland	Department of Invasive Cardiology, Medical University of Bialystok	Bialystok
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
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	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

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Silesia	Wojciech Wojakowski

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TLR	target lesion revascularisation	3 years
Secondary	DOCE	composite of cardiac death, TLR, and target vessel MI	3 years
Secondary	TVR	target vessel revascularization	3 years
Secondary	TV-MI	target vessel myocardial infarction	3 years
Secondary	cardiac death		3 years
Secondary	myocardial infarction		3 years