Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
Acronym
THUEBIS Study
Study hypothesis
Simple Percutaneous Coronary Intervention (PCI) of bifurcation lesions is not inferior to complex PCI
Ethics approval
Ethics committee, Thüringen Health Centre (Landesärztekammer Thüringen), approved on 25 June 2003 (ref: kl/1065/03/111)
Study design
Prospective randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Coronary bifurcation lesion
Intervention
Complex vs simple PCI
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Target Lesion Revascularization (TLR) at 6 months
Secondary outcome measures
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
Overall trial start date
01/09/2004
Overall trial end date
01/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Participant 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
Recruitment start date
01/09/2004
Recruitment end date
01/12/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Hetzelstift
Neustadt an der Weinstrasse
67434
Germany
Funders
Funder type
Hospital/treatment centre
Funder name
Berka Clinic, Department of Cardiology (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20031771
Publication citations
-
Results
Korn HV, Yu J, Ohlow MA, Huegl B, Schulte W, Wagner A, Wassmer G, Gruene S, Petek O, Lauer B, Interventional therapy of bifurcation lesions: a TIMI flow-guided concept to treat side branches in bifurcation lesions--a prospective randomized clinical study (Thueringer bifurcation study, THUEBIS study as pilot trial)., Circ Cardiovasc Interv, 2009, 2, 6, 535-542, doi: 10.1161/CIRCINTERVENTIONS.108.833046.