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Interventional Therapy Of Bifurcation Lesions: A New Approach Using Drug-eluting Balloons For The Main Branch And/Or For The Side Branch: The DEBIFU Registry

Interventional Therapy Of Bifurcation Lesions: A New Approach Using Drug-eluting Balloons For The Main Branch And/Or For The Side Branch: The DEBIFU Registry - DEBIFU

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024202
Enrollment
100
Registered
2021-01-28
Start date
2012-05-10
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart disease, coronary artery Stenosis, bifurcation stenosis

Interventions

Group 1: The registry should include male or female patients older than 18 years of age with a diagnosis of stable angina, silent ischemia or NSTEMI. Additional eligibility criteria include the pres

Sponsors

Department of Cardiology, Hetzelstift
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 95 Years

Inclusion criteria

Inclusion criteria: We include male or female patients older than 18 years with a diagnosis of stable angina, silent ischemia or acute coronary syndromes with a de novo coronary bifurcation lesion, defined as stenosis > 50 % determined by visual estimation in either the main branch (MB) and/or the ostium of the side branch (SB). Both branches were required to have at least a TIMI flow of II or III, a reference vessel size > 2.25 mm upon visual estimation.

Exclusion criteria

Exclusion criteria: Patients exclusion criteria were myocardial infarction in the 24 hours preceding treatment (STEMI), stenosis of the left main coronary artery unprotected by a graft, cardiogenic shock, angiographic visible thrombus within the target lesion, restenosis or total occlusion of the target lesion, life expectancy < 1 year or suspected intolerance to paclitaxel, aspirin, clopidogrel, ticagrelor or prasugrel.

Design outcomes

Primary

MeasureTime frame
Clinically driven or ischemia guided target lesion revascularization at 9 months follow up. MACE (for definitions see below) after 9 months • Death • Myocardial infarction (NSTEMI/STEMI) • Stent thrombosis, thrombosis of the target lesion • CABG • TLR • TVR

Secondary

MeasureTime frame
Technical aspects • incidence of needed stenting of the main branch • incidende of needed stenting of the side branch • incidence of final kissing • incidence of pure PCI using drug coated balloons without stenting

Countries

Germany

Contacts

Public ContactHubertus von Korn

Department of Cardiology, Hetzelstift

hubertus.vonkorn@marienhaus.de06321-859-4000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026