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 |
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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
Scientific
Hetzelstift
Neustadt an der Weinstrasse
67434
Germany
Study information
Study design | Prospective randomized controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/09/2004 |
Completion date | 01/12/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Hetzelstift
Neustadt an der Weinstrasse
67434
Germany
67434
Germany
Sponsor information
Berka Clinic, Department of Cardiology (Zentralklinik Bad Berka, Klinik für Kardiologie) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Robert-Koch-Allee 9
Bad Berka
99437
Germany
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |