Welcome
Support Centre
17 September 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
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 10.1186/ISRCTN22637771
ClinicalTrials.gov identifier
EudraCT number
Public title 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)
Scientific title
Acronym THUEBIS Study
Serial number at source 001
Study hypothesis Simple Percutaneous Coronary Intervention (PCI) of bifurcation lesions is not inferior to complex PCI
Lay summary
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
Countries of recruitment Germany
Disease/condition/study domain Coronary bifurcation lesion
Participants - 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.
Participants - 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
Anticipated start date 01/09/2004
Anticipated end date 01/12/2006
Status of trial Completed
Patient information material
Target number of participants 110
Interventions Complex vs simple PCI
Primary outcome measure(s) Target Lesion Revascularization (TLR) at 6 months
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
Sources of funding Berka Clinic, Department of Cardiology (Germany)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20031771
Contact name Dr  Hubertus  von Korn
  Address Hetzelstift
  City/town Neustadt an der Weinstrasse
  Zip/Postcode 67434
  Country Germany
Sponsor Berka Clinic, Department of Cardiology (Zentralklinik Bad Berka, Klinik für Kardiologie) (Germany)
  Address Robert-Koch-Allee 9
  City/town Bad Berka
  Zip/Postcode 99437
  Country Germany
Date applied 23/12/2007
Last edited 06/01/2010
Date ISRCTN assigned 14/02/2008
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.