European trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55628

Enrollment

140

Registered

2018-12-21

Start date

2019-03-25

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bifurcation lesion

Interventions

Intra vascular optical coherence tomography (OCT)

Eligibility

Age

18 Years to 99 Years

Inclusion 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.

Exclusion criteria

Exclusion criteria: STEMI within 72 hours Cardiogenic shock Prior CABG or planned CABG Renal failure with GFR II Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).

Design outcomes

Primary

Measure	Time frame
Combined endpoint of median two-year MACE (cardiac death, target lesion myocardial infarction, ischemic driven target lesion revascularization)	—

Secondary

Measure	Time frame
Clinical endpoints: All-cause mortality 1,12,24,36,48,60 and 120 months. Cardiac death, myocardial infarction, stent thrombosis(definite/ possible/probable), myocardial infarction or revascularization of target lesion/ bifurcation/vessel, any revascularization and CSS angina class at 1,12,24,36,48 and 60 months. Procedural endpoint: Contrast volume, procedure time, fluoroscopy time, number of stent implanted in target lesion, number of stents implanted in non-target lesion, total stent length in target lesion, total stent length and procedural success (TIMI III flow and less than 30% diameter stenosis in target segments) OCT guided group: successful final OCT acquisition in main vessel/side branch. Successful treatment specific to OCT acquisition. Angiographic endpoints: Target bifurcation: minimal luminal diameter and diameter stenosis post-PCI (proximal edge, proximal MV, bifurcation core segment, distal MV ostium, distal MV, distal edge, SB ostium, SB, SB edge) Non-target lesions: minimal luminal diameter and diameter stenosis post PCI (proximal edge, in-stent, distal edge)	—

Measure

Time frame

Clinical endpoints: All-cause mortality 1,12,24,36,48,60 and 120 months. Cardiac death, myocardial infarction, stent thrombosis(definite/ possible/probable), myocardial infarction or revascularization of target lesion/ bifurcation/vessel, any revascularization and CSS angina class at 1,12,24,36,48 and 60 months. Procedural endpoint: Contrast volume, procedure time, fluoroscopy time, number of stent implanted in target lesion, number of stents implanted in non-target lesion, total stent length in target lesion, total stent length and procedural success (TIMI III flow and less than 30% diameter stenosis in target segments) OCT guided group: successful final OCT acquisition in main vessel/side branch. Successful treatment specific to OCT acquisition. Angiographic endpoints: Target bifurcation: minimal luminal diameter and diameter stenosis post-PCI (proximal edge, proximal MV, bifurcation core segment, distal MV ostium, distal MV, distal edge, SB ostium, SB, SB edge) Non-target lesions: minimal luminal diameter and diameter stenosis post PCI (proximal edge, in-stent, distal edge)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)