Interventional therapy of bifurcation lesions: A flow-guided concept to treat side branches in bifurcation lesions - a prospective randomized clinical study (THUEringer BIfurcation Study, THUEBIS-Study)

ISRCTN	ISRCTN22637771
DOI	https://doi.org/10.1186/ISRCTN22637771
Protocol serial number	001
Sponsor	Berka Clinic, Department of Cardiology (Zentralklinik Bad Berka, Klinik für Kardiologie) (Germany)
Funder	Berka Clinic, Department of Cardiology (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Hubertus von Korn
Scientific

Hetzelstift
Neustadt an der Weinstrasse
67434
Germany

Primary study design	Interventional
Study design	Prospective randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	THUEBIS Study
Study objectives	Simple Percutaneous Coronary Intervention (PCI) of bifurcation lesions is not inferior to complex PCI
Ethics approval(s)	Ethics committee, Thüringen Health Centre (Landesärztekammer Thüringen), approved on 25 June 2003 (ref: kl/1065/03/111)
Health condition(s) or problem(s) studied	Coronary bifurcation lesion
Intervention	Complex vs simple PCI
Intervention type	Other
Primary outcome measure(s)	Target Lesion Revascularization (TLR) at 6 months
Key secondary outcome measure(s)	1. Incidence of binary restenosis >50% (MB) at 6 months 2. Calculated late-luminal loss evaluated by Quantitative Coronary Angiography (QCA) 6 months after PCI 3. Incidence of Target Vessel Revascularization (TVR) and Major Adverse Cardiac Events (MACE) at 6 months
Completion date	01/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	110
Key inclusion criteria	1. Male or female patients older than 18 years of age 2. Diagnosis of stable angina or silent ischemia 3. Presence of a de novo, true coronary bifurcation lesion, defined as stenosis >50% in both the Main Branch (MB) and the ostium of the Side Branch (SB). Both branches were required to have a Thrombolysis In Myocardial Infarction (TIMI) flow of at least 2 or 3 as well as a reference vessel size >2.25 mm by visual estimation or a relevant SB which the operator would not have wanted to loosen during the procedure. If two commensurate vessels were present, the main branch was defined as the largest of the two vessels involved.
Key exclusion criteria	1. A myocardial infarction in the 24 hours preceding treatment (STEMI and NSTEMI) 2. Stenosis of the left main coronary artery unprotected by a graft 3. Cardiogenic shock 4. Angiographically visible thrombus within the target lesion, restenosis or total occlusion of the target lesion 5. Life expectancy <1 year 6. Suspected intolerance to paclitaxel, aspirin or clopidogrel
Date of first enrolment	01/09/2004
Date of final enrolment	01/12/2006

Hetzelstift

Neustadt an der Weinstrasse
67434
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2009		Yes	No