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
Secondary identifying numbers 001
Submission date
23/12/2007
Registration date
14/02/2008
Last edited
06/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hubertus von Korn
Scientific

Hetzelstift
Neustadt an der Weinstrasse
67434
Germany

Study information

Study designProspective randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymTHUEBIS Study
Study objectivesSimple 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) studiedCoronary bifurcation lesion
InterventionComplex vs simple PCI
Intervention typeOther
Primary outcome measureTarget Lesion Revascularization (TLR) at 6 months
Secondary outcome measures1. 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 study start date01/09/2004
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants110
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2004
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Hetzelstift
Neustadt an der Weinstrasse
67434
Germany

Sponsor information

Berka Clinic, Department of Cardiology (Zentralklinik Bad Berka, Klinik für Kardiologie) (Germany)
Hospital/treatment centre

Robert-Koch-Allee 9
Bad Berka
99437
Germany

ROR logo "ROR" https://ror.org/00zfe1b87

Funders

Funder type

Hospital/treatment centre

Berka Clinic, Department of Cardiology (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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