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Identification of risk factors for acute coronary events by Optical Coherence Tomography after STEMI and NSTEMI in patients with residual non-flow limiting lesions: the PECTUS-obs Trial (observational cohort)

Identification of risk factors for acute coronary events by Optical Coherence Tomography after STEMI and NSTEMI in patients with residual non-flow limiting lesions: the PECTUS-obs Trial (observational cohort) - the PECTUS-obs trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48078
Enrollment
324
Registered
2018-09-07
Start date
2018-12-14
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Atherosclerosis, vulnerable plaque atherosclerosis

Interventions

No intervention. OCT measurement.&nbsp

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the main trial: - Informed consent must be obtained. - Patients are hospitalized with a STEMI or NSTEMI (or have been in the last 6 weeks), for which they are subjected to invasive coronary angiography. - Invasive coronary angiography shows residual non-culprit CAD (target lesion(s)) - Patient has >= 1 target lesion(s) on angiography with following additional characteristics: - Lesion has visual stenosis of 30-90%. - Lesion is non-obstructive (FFR>0.80). - Lesion is not in-stent restenosis. Inclusion criteria for the registry: Inclusion criteria for the registry are the same as for the main trial, except: - All target lesions are obstructive (FFR

Exclusion criteria

Exclusion criteria: - Refusal or inability to provide informed consent. - = 3 at time of inclusion. - Previous CABG. - Indication for revascularization by CABG. - Anatomy of target lesion(s) unsuitable for OCT catheter crossing or imaging (aorta-ostial lesions, too small diameter segment, severe calcifications, chronic total occlusion, lesions located to distally) - Pregnancy. - Estimated life expectancy

Design outcomes

Secondary

MeasureTime frame
The primary outcome at 1 and 5 year follow-up. Also target lesion/vessel failure and target lesion/vessel revascularisation at 1,2, and 5 years.

Primary

MeasureTime frame
A composite of major adverse cardiovascular events (all-cause mortality, non-fatal myocardial infarction (STEMI or NSTEMI), or unplanned revascularization) at 2 year follow-up.

Countries

Aruba, Estonia, Netherlands, Russian Federation

Contacts

Public ContactJHQ Mol

Radboud Universitair Medisch Centrum

niels.vanroyen@radboudumc.nl(024) 361 45 33

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)