The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER) (OCTOBER)

• ClinicalTrials.gov Identifier: NCT03171311
• Recruitment Status: Active, not recruiting
• First Posted: May 31, 2017
• Last Update Posted: June 22, 2023
• Sponsor: Aarhus University Hospital Skejby
• Collaborator: Abbott
• Information provided by (Responsible Party): Evald Hoej Christiansen, Aarhus University Hospital Skejby

Study Description

Brief Summary:

The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation

Condition or disease	Intervention/treatment	Phase
Ischaemic Heart Disease; Ischemic Heart Disease	Procedure: Angiographic guided PCI; Procedure: OCT guided PCI	Not Applicable

Detailed Description:

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -
• Actual Study Start Date: July 5, 2017
• Actual Primary Completion Date: March 25, 2022
• Estimated Study Completion Date: May 2029

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Angiographic guided PCI; Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).	Procedure: Angiographic guided PCI; Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques; Other Name: PCI, percutaneous transluminal coronary angioplasty (PTCA)
Experimental: OCT guided PCI; OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)	Procedure: OCT guided PCI; OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans; Other Name: OCT

Outcome Measures

Primary Outcome Measures :

1. Combined endpoint of major adverse cardiac events (MACE) [ Time Frame: 24 months ]
   Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization

Secondary Outcome Measures :

1. Study bifurcation oriented composite endpoint [ Time Frame: 1 month ]
   Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
2. Study bifurcation oriented composite endpoint [ Time Frame: 12 months ]
   Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
3. Study bifurcation oriented composite endpoint [ Time Frame: 24 months ]
   Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
4. Study bifurcation oriented composite endpoint [ Time Frame: 36 months ]
   Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
5. Study bifurcation oriented composite endpoint [ Time Frame: 48 months ]
   Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
6. Study bifurcation oriented composite endpoint [ Time Frame: 60 months ]
   Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
7. Patient oriented composite endpoint [ Time Frame: 1 month ]
   Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
8. Patient oriented composite endpoint [ Time Frame: 12 months ]
   Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
9. Patient oriented composite endpoint [ Time Frame: 24 months ]
   Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
10. Patient oriented composite endpoint [ Time Frame: 36 months ]
    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
11. Patient oriented composite endpoint [ Time Frame: 48 months ]
    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
12. Patient oriented composite endpoint [ Time Frame: 60 months ]
    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
13. All-cause mortality [ Time Frame: 1 month ]
    Death of any cause including cardiac deaths and non-natural causes of death
14. All-cause mortality [ Time Frame: 12 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
15. All-cause mortality [ Time Frame: 24 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
16. All-cause mortality [ Time Frame: 36 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
17. All-cause mortality [ Time Frame: 48 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
18. All-cause mortality [ Time Frame: 60 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
19. All-cause mortality [ Time Frame: 120 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
20. Cardiac death [ Time Frame: 1 month ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
21. Cardiac death [ Time Frame: 12 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
22. Cardiac death [ Time Frame: 24 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
23. Cardiac death [ Time Frame: 36 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
24. Cardiac death [ Time Frame: 48 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
25. Cardiac death [ Time Frame: 60 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
26. Myocardial infarction [ Time Frame: 1 month ]
    Procedure and non-procedure related myocardial infarction
27. Myocardial infarction [ Time Frame: 12 months ]
    Procedure and non-procedure related myocardial infarction
28. Myocardial infarction [ Time Frame: 24 months ]
    Procedure and non-procedure related myocardial infarction
29. Myocardial infarction [ Time Frame: 36 months ]
    Procedure and non-procedure related myocardial infarction
30. Myocardial infarction [ Time Frame: 48 months ]
    Procedure and non-procedure related myocardial infarction
31. Myocardial infarction [ Time Frame: 60 months ]
    Procedure and non-procedure related myocardial infarction
32. Stent Thrombosis [ Time Frame: 1 month ]
    Definite, possible or probable
33. Stent Thrombosis [ Time Frame: 12 months ]
    Definite, possible or probable
34. Stent Thrombosis [ Time Frame: 24 months ]
    Definite, possible or probable
35. Stent Thrombosis [ Time Frame: 36 months ]
    Definite, possible or probable
36. Stent Thrombosis [ Time Frame: 48 months ]
    Definite, possible or probable
37. Stent Thrombosis [ Time Frame: 60 months ]
    Definite, possible or probable
38. Target lesion myocardial infarction [ Time Frame: 1 month ]
    Myocardial infarction related to an index treated lesion
39. Target lesion myocardial infarction [ Time Frame: 12 months ]
    Myocardial infarction related to an index treated lesion
40. Target lesion myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction related to an index treated lesion
41. Target lesion myocardial infarction [ Time Frame: 36 months ]
    Myocardial infarction related to an index treated lesion
42. Target lesion myocardial infarction [ Time Frame: 48 months ]
    Myocardial infarction related to an index treated lesion
43. Target lesion myocardial infarction [ Time Frame: 60 months ]
    Myocardial infarction related to an index treated lesion
44. Target lesion revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of target lesion
45. Target lesion revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of target lesion
46. Target lesion revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of target lesion
47. Target lesion revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of target lesion
48. Target lesion revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of target lesion
49. Target lesion revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of target lesion
50. Target bifurcation myocardial infarction [ Time Frame: 1 month ]
    Myocardial infarction related to the index bifurcation
51. Target bifurcation myocardial infarction [ Time Frame: 12 months ]
    Myocardial infarction related to the index bifurcation
52. Target bifurcation myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction related to the index bifurcation
53. Target bifurcation myocardial infarction [ Time Frame: 36 months ]
    Myocardial infarction related to the index bifurcation
54. Target bifurcation myocardial infarction [ Time Frame: 48 months ]
    Myocardial infarction related to the index bifurcation
55. Target bifurcation myocardial infarction [ Time Frame: 60 months ]
    Myocardial infarction related to the index bifurcation
56. Target bifurcation revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of target bifurcation
57. Target bifurcation revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
58. Target bifurcation revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
59. Target bifurcation revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
60. Target bifurcation revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
61. Target bifurcation revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
62. Target vessel revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of target vessel
63. Target vessel revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of target vessel
64. Target vessel revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of target vessel
65. Target vessel revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of target vessel
66. Target vessel revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of target vessel
67. Target vessel revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of target vessel
68. Any revascularisation [ Time Frame: 1 month ]
    Any repeat revascularization except staged revascularization planned during the index procedure
69. Any revascularisation [ Time Frame: 12 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
70. Any revascularisation [ Time Frame: 24 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
71. Any revascularisation [ Time Frame: 36 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
72. Any revascularisation [ Time Frame: 48 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
73. Any revascularisation [ Time Frame: 60 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
74. CCS angina class [ Time Frame: 1 month ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
75. CCS angina class [ Time Frame: 12 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
76. CCS angina class [ Time Frame: 24 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
77. CCS angina class [ Time Frame: 36 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
78. CCS angina class [ Time Frame: 48 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
79. CCS angina class [ Time Frame: 60 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
80. Post-PCI minimal lumen diameter in the stented proximal main vessel segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
81. Post-PCI minimal lumen diameter in the stented distal main vessel segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment
82. Post-PCI minimal lumen diameter in the treated side branch vessel segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
83. Post-PCI minimal lumen diameter in the proximal main vessel edge segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
84. Post-PCI minimal lumen diameter in the distal main vessel edge segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
85. Post-PCI minimal lumen diameter in the side branch vessel edge segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
86. Post-PCI minimal lumen diameter in the stented bifurcation core segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment
87. Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
88. Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment
89. Post-PCI diameter stenosis in the stented proximal main vessel segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
90. Post-PCI diameter stenosis in the stented distal main vessel segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment
91. Post-PCI diameter stenosis in the treated side branch vessel segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
92. Post-PCI diameter stenosis in the proximal main vessel edge segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
93. Post-PCI diameter stenosis in the distal main vessel edge segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
94. Post-PCI diameter stenosis in the side branch vessel edge segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
95. Post-PCI diameter stenosis in the stented bifurcation core segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment
96. Post-PCI diameter stenosis in the stented distal main vessel ostium segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
97. Post-PCI diameter stenosis in the treated side branch ostium segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment
98. Post-PCI minimal lumen diameter in non-bifurcation target stented segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
99. Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent)
100. Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment [ Time Frame: 1 day ]
     Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent)
101. Post-PCI diameter stenosis in non-bifurcation target stented segment [ Time Frame: 1 day ]
     Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
102. Post-PCI diameter stenosis in non-bifurcation target proximal edge segment [ Time Frame: 1 day ]
     Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment
103. Post-PCI diameter stenosis in non-bifurcation target distal edge segment [ Time Frame: 1 day ]
     Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
• Age ≥18 yrs.
• Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.

Angiographic inclusion criteria:

• Native coronary bifurcation de novo lesion
• More than 50% diameter stenosis in the main vessel (MV)
• More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium.
• Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB.

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:

• STEMI within 72 hours
• Cardiogenic shock
• Prior coronary artery bypass grafting (CABG) or planned CABG
• Renal failure with glomerular filtration rate (GFR) <50 mL/min per 1.73 m2
• Active bleeding or coagulopathy
• Life expectancy < 2 years
• Ejection fraction < 30%
• New York Heart Association (NYHA) class > II
• Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).

Angiographic exclusion criteria:

• Severe tortuosity around target bifurcation
• Chronic total occlusions
• Massive thrombus in Left main coronary artery
• Medina 0.0.1 lesions

Contacts and Locations

Locations

Belgium

Ziekenhuis Oost-Limburg (ZOL) Genk

Genk, Belgium, 3600

Leuven University Hospital

Leuven, Belgium, 3000

Denmark

Aalborg University Hospital

Aalborg, Denmark, 9100

Aarhus University Hospital Skejby

Aarhus N, Denmark, 8200

Gentofte Hospital

Gentofte, Denmark, 2820

Rigshospitalet

København Ø, Denmark, 2100

Odense University Hospital

Odense, Denmark, 5000

Zealand University Hospital, Roskilde Sygehus

Roskilde, Denmark, 4000

Estonia

Estonia Medical Centre

Tallinn, Estonia, 13419

Finland

Tampere University Hospital

Tampere, Finland, 33520

Germany

Vivantes Klinikum im Friedrichshain

Berlin, Germany, 10249

Universitäres Herzzentrum Hamburg

Hamburg, Germany, 20246

Cardiologicum Hamburg

Hamburg, Germany, 22041

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany, 24105

Ireland

University Hospital Galway

Galway, Ireland, H91YR71

Italy

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Cona, Italy, 44124

Gemelli General Hospital, Catholic University of the Sacred Heart

Rome, Italy, 00168

Latvia

Latvia Centre of Cardiology

Riga, Latvia, LV-1002

Netherlands

Northwest Hospital Alkmaar

Alkmaar, Netherlands, 1815

VU University Medical Center (VUMC)

Amsterdam, Netherlands, 1081 HV

St Antonius Ziekenhuis

Nieuwegein, Netherlands, 3435 CM

Norway

Hospital of Southern Norway, Arendal

Arendal, Norway, 4604

Haukeland University Hospital, Bergen

Bergen, Norway

Oslo University Hospital, Rikshospitalet

Oslo, Norway, 0424

Oslo University Hospital - Ullevål

Oslo, Norway, 0450

Trondheim University Hospital

Trondheim, Norway

Poland

Medical University of Warsaw

Warsaw, Poland, 02-097

Sweden

Karolinska University Hospital Huddinge

Huddinge, Stockholm, Sweden, 14157

Sahlgrenska University Hospital

Göteborg, Sweden, 413 45

Örebro University Hospital

Orebro, Sweden, 70185

Södersjukhuset

Stockholm, Sweden, 118 83

United Kingdom

Belfast Health and Social Care Trust

Belfast, United Kingdom, BT9 7AB

Royal Bournemouth Hospital

Bournemouth, United Kingdom, BH77DW

Sussex Cardiac Centre

Brighton, United Kingdom, BN2 5BE

Golden Jubilee Hospital

Glasgow, United Kingdom, G81 4DY

St George's Hospital

London, United Kingdom, SW17 0QT

University Hospital South Manchester, Wythenshawe Hospital

Manchester, United Kingdom, M239LT

Morriston Hospital

Swansea, United Kingdom, SA6 6NL

Sponsors and Collaborators

Aarhus University Hospital Skejby

Abbott

Investigators

• Study Chair: Evald H Christiansen, MD, PhD; Aarhus University Hospital, Denmark

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Evald Hoej Christiansen, MD, phd, Aarhus University Hospital Skejby
• ClinicalTrials.gov Identifier: NCT03171311
• Other Study ID Numbers: 1-10-72-161-16
• First Posted: May 31, 2017
• Last Update Posted: June 22, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Is decided after primary endpoint assessment and requires regulatory approval

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases