Condition category
Circulatory System
Date applied
23/12/2007
Date assigned
14/02/2008
Last edited
06/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hubertus von Korn

ORCID ID

Contact details

Hetzelstift
Neustadt an der Weinstrasse
67434
Germany

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 measures

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

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

Sponsor information

Organisation

Berka Clinic, Department of Cardiology (Zentralklinik Bad Berka, Klinik für Kardiologie) (Germany)

Sponsor details

Robert-Koch-Allee 9
Bad Berka
99437
Germany

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20031771

Publication citations

  1. 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.

Additional files

Editorial Notes