Nordic-Baltic Coronary Revascularization Study in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion.
NCT ID: NCT03538886
Last Updated: 2021-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2018-06-01
2019-07-31
Brief Summary
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Detailed Description
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According to recent European guidelines, significant pLAD disease may be treated by PCI or by CABG. This recommendation is based on two meta-analyses including 1.210 and 1.952 randomized and non-randomized patients. Generally, the patients were followed for 4-5 years. The analyses reported similar rates of mortality, MI and stroke, but more repeat revascularizations after PCI. Only one study including129 patients provided more than 5-year follow-up. Thus, the there is limited documentation for long-term effect of PCI vs. surgical re-vascularization in pLAD disease.
The American 2014 Guidelines on coronary revascularization recommends CABG for improved survival in patients with solitary proximal LAD stenosis. CABG
The angiographic 90% LIMA patency rate after 1, 2 and 3 decades is well described and suggestive of a survival benefit of surgical revascularization.
Therefore, there is scientific background for an CABG LIMA-to-LAD vs. PCI comparison in 1-VD patients with a pLAD lesion.
Substantiated expectations:
* PCI is superior to bypass operation concerning short-term quality of life.
* Off-pump LIMA-to-LAD is superior to PCI concerning long-term all-cause mortality.
* Long-term (≥10-year) follow-up is essential to evaluate coronary revascularization strategies.
* Outcome may be dependent on lesion complexity, diabetes and gender.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Percutaneous coronary intervention (PCI)
Currently, percutaneous coronary intervention (PCI) using balloon and drug eluting stents is the treatment of choice for treatment of a proximal LAD lesion.
Percutaneous coronary intervention (PCI)
Revascularization of LAD lesion by PCI
Coronary artery bypass grafting (CABG)
Coronary artery bypass grafting is a well established treatment with documented excellent long-term results for the treatment of proximal LAD lesion.
Coronary artery bypass grafting (CABG)
Revascularization of LAD lesion by CABG
Interventions
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Coronary artery bypass grafting (CABG)
Revascularization of LAD lesion by CABG
Percutaneous coronary intervention (PCI)
Revascularization of LAD lesion by PCI
Eligibility Criteria
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Inclusion Criteria
1-VD patients with stable coronary artery disease or stabilized unstable angina pectoris/NSTEMI or silent ischemia Proximal LAD (pLAD) stenosis (\>90% by visual assessment or FFR \<80% The lesion may be treated by both PCI and surgery
Exclusion Criteria
Significant LM disease. Earlier CABG. PCI within 3 months. Significant valvular heart disease. Renal failure on dialysis Earlier disabling stroke Relative or absolute contraindication to dual antiplatelet therapy. Allergy relevant to the study treatments. Age \< 18 years. Study required information and consent suboptimal or impossible.
18 Years
ALL
No
Sponsors
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Oulu University Hospital
OTHER
Region Örebro County
OTHER
Pauls Stradins Clinical University Hospital
OTHER
Aalborg University Hospital
OTHER
Responsible Party
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Leif Thuesen
Senior interventional cardiologist
Principal Investigators
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Leif Thuesen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Aalborg University Hospital
Jan Jesper Andreasen, Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiothoracic Surgery, Aalborg University Hospital
Peter Sogaard, Prof
Role: STUDY_CHAIR
Department of Cardiology, aaalborg University Hospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Countries
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Other Identifiers
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NOBLE-LAD_Protocol version 3
Identifier Type: -
Identifier Source: org_study_id
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