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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation
Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results.
It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome.
Hypothesis: Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI.
Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique.
Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiographic guided PCI | Active Comparator | Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS). |
|
| OCT guided PCI | Experimental | OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiographic guided PCI | Procedure | Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint of major adverse cardiac events (MACE) | Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 1 month |
| Study bifurcation oriented composite endpoint |
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Inclusion Criteria:
Angiographic inclusion criteria:
Functional inclusion criteria:
Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant.
Procedural inclusion criteria:
Indication for two-stent technique or one-stent technique with kissing balloon inflation
Exclusion Criteria:
Angiographic exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evald H Christiansen, MD, PhD | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg (ZOL) Genk | Genk | 3600 | Belgium | |||
| Leuven University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37634149 | Derived | Holm NR, Andreasen LD, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, McNeice A, Kajander OA, Heestermans T, Kische S, Eftekhari A, Spratt JC, Christiansen EH; OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27. | |
| 30205242 |
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Is decided after primary endpoint assessment and requires regulatory approval
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|
| OCT guided PCI | Procedure | OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans |
|
|
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
| 12 months |
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 24 months |
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 36 months |
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 48 months |
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 60 months |
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 1 month |
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 12 months |
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 24 months |
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 36 months |
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 48 months |
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 60 months |
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 1 month |
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 12 months |
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 24 months |
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 36 months |
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 48 months |
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 60 months |
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 120 months |
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 1 month |
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 12 months |
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 24 months |
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 36 months |
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 48 months |
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 60 months |
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 1 month |
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 12 months |
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 24 months |
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 36 months |
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 48 months |
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 60 months |
| Stent Thrombosis | Definite, possible or probable | 1 month |
| Stent Thrombosis | Definite, possible or probable | 12 months |
| Stent Thrombosis | Definite, possible or probable | 24 months |
| Stent Thrombosis | Definite, possible or probable | 36 months |
| Stent Thrombosis | Definite, possible or probable | 48 months |
| Stent Thrombosis | Definite, possible or probable | 60 months |
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 1 month |
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 12 months |
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 24 months |
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 36 months |
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 48 months |
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 60 months |
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 1 month |
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 12 months |
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 24 months |
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 36 months |
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 48 months |
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 60 months |
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 1 month |
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 12 months |
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 24 months |
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 36 months |
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 48 months |
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 60 months |
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 1 month |
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 12 months |
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 24 months |
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 36 months |
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 48 months |
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 60 months |
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 1 month |
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 12 months |
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 24 months |
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 36 months |
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 48 months |
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 60 months |
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 1 month |
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 12 months |
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 24 months |
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 36 months |
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 48 months |
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 60 months |
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 1 month |
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 12 months |
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 24 months |
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 36 months |
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 48 months |
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 60 months |
| Contrast volume | Contrast volume | Baseline, after final baseline procedure |
| Procedure time | Procedure time | Baseline, after final baseline procedure |
| Fluoroscopy time | Fluoroscopy time | Baseline, after final baseline procedure |
| Number of stents implanted in target lesion | Number of stents implanted in target lesion | Baseline, after final baseline procedure |
| Number of stents implanted in non-target lesion | Number of stents implanted in non-target lesion | Baseline, after final baseline procedure |
| Total stent length in target lesion | Total stent length in target lesion | Baseline, just after final baseline procedure |
| Total stent length in total | Total stent length in total | Baseline, just after final baseline procedure |
| Procedural success | TIMI III flow and less than 30% diameter stenosis in target segments | Baseline, just after final baseline procedure |
| OCT-guiding group: Successful final OCT acquisition in MV | For OCT-guided enrollments. Successful final OCT acquisition in main vessel. Success defined as analyzable stented segment. | Baseline, just after final baseline procedure |
| OCT-guiding group: Successful final OCT acquisition in SB | For OCT-guided enrollments. Successful final OCT acquisition in side branch. Success defined as analyzable stented segment. | Baseline, just after final baseline procedure |
| OCT-guiding group: Successful treatment specific OCT acquisitions | OCT performed succesfully in protocol-defined vessels at all protocol-defined time-points during baseline procedure | Baseline, after final baseline procedure |
| Post-PCI minimal lumen diameter in the stented proximal main vessel segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment | Baseline, after final baseline procedure |
| Post-PCI minimal lumen diameter in the stented distal main vessel segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment | Baseline, after final baseline procedure |
| Post-PCI minimal lumen diameter in the treated side branch vessel segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment | Baseline, just after final baseline procedure |
| Post-PCI minimal lumen diameter in the proximal main vessel edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent) | Baseline, just after final baseline procedure |
| Post-PCI minimal lumen diameter in the distal main vessel edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent) | Baseline, just after final baseline procedure |
| Post-PCI minimal lumen diameter in the side branch vessel edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon) | Baseline, just after final baseline procedure |
| Post-PCI minimal lumen diameter in the stented bifurcation core segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment | Baseline, after final baseline procedure |
| Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment | Baseline, just after final baseline procedure |
| Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in the stented proximal main vessel segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in the stented distal main vessel segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment | Baseline, after final baseline procedure |
| Post-PCI diameter stenosis in the treated side branch vessel segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment | Baseline, after final baseline procedure |
| Post-PCI diameter stenosis in the proximal main vessel edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent) | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in the distal main vessel edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent) | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in the side branch vessel edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon) | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in the stented bifurcation core segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in the stented distal main vessel ostium segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in the treated side branch ostium segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment | Baseline, just after final baseline procedure |
| Post-PCI minimal lumen diameter in non-bifurcation target stented segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment | Baseline, after final baseline procedure |
| Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent) | Baseline, after final baseline procedure |
| Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent) | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in non-bifurcation target stented segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in non-bifurcation target proximal edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment | Baseline, just after final baseline procedure |
| Post-PCI diameter stenosis in non-bifurcation target distal edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment | Baseline, just after final baseline procedure |
| Leuven |
| 3000 |
| Belgium |
| Aalborg University Hospital | Aalborg | 9100 | Denmark |
| Aarhus University Hospital Skejby | Aarhus N | 8200 | Denmark |
| Gentofte Hospital | Gentofte Municipality | 2820 | Denmark |
| Rigshospitalet | København Ø | 2100 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Zealand University Hospital, Roskilde Sygehus | Roskilde | 4000 | Denmark |
| Estonia Medical Centre | Tallinn | 13419 | Estonia |
| Tampere University Hospital | Tampere | 33520 | Finland |
| Vivantes Klinikum im Friedrichshain | Berlin | State of Berlin | 10249 | Germany |
| Universitäres Herzzentrum Hamburg | Hamburg | 20246 | Germany |
| Cardiologicum Hamburg | Hamburg | 22041 | Germany |
| Universitätsklinikum Schleswig-Holstein Campus Kiel | Kiel | 24105 | Germany |
| University Hospital Galway | Galway | H91YR71 | Ireland |
| Azienda Ospedaliero-Universitaria di Ferrara | Ferrara | Cona | 44124 | Italy |
| Gemelli General Hospital, Catholic University of the Sacred Heart | Rome | 00168 | Italy |
| Latvia Centre of Cardiology | Riga | LV-1002 | Latvia |
| Northwest Hospital Alkmaar | Alkmaar | 1815 | Netherlands |
| VU University Medical Center (VUMC) | Amsterdam | 1081 HV | Netherlands |
| St Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Hospital of Southern Norway, Arendal | Arendal | 4604 | Norway |
| Haukeland University Hospital, Bergen | Bergen | Norway |
| Oslo University Hospital, Rikshospitalet | Oslo | 0424 | Norway |
| Oslo University Hospital - Ullevål | Oslo | 0450 | Norway |
| Trondheim University Hospital | Trondheim | Norway |
| Medical University of Warsaw | Warsaw | 02-097 | Poland |
| Karolinska University Hospital Huddinge | Huddinge | Stockholm County | 14157 | Sweden |
| Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| Örebro University Hospital | Örebro | 70185 | Sweden |
| Södersjukhuset | Stockholm | 118 83 | Sweden |
| Belfast Health and Social Care Trust | Belfast | BT9 7AB | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | BH77DW | United Kingdom |
| Sussex Cardiac Centre | Brighton | BN2 5BE | United Kingdom |
| Golden Jubilee Hospital | Glasgow | G81 4DY | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| University Hospital South Manchester, Wythenshawe Hospital | Manchester | M239LT | United Kingdom |
| Morriston Hospital | Swansea | SA6 6NL | United Kingdom |
| Derived |
| Holm NR, Andreasen LN, Walsh S, Kajander OA, Witt N, Eek C, Knaapen P, Koltowski L, Gutierrez-Chico JL, Burzotta F, Kockman J, Ormiston J, Santos-Pardo I, Laanmets P, Mylotte D, Madsen M, Hjort J, Kumsars I, Ramunddal T, Christiansen EH. Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER). Am Heart J. 2018 Nov;205:97-109. doi: 10.1016/j.ahj.2018.08.003. Epub 2018 Aug 16. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015906 | Angioplasty, Balloon, Coronary |
| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D062645 | Percutaneous Coronary Intervention |
| D019060 | Minimally Invasive Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D008919 | Investigative Techniques |
Not provided
Not provided