NL-OMON48078RecruitingNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 329
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •- 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<=0.80).
Exclusion Criteria
- •- Refusal or inability to provide informed consent.
- •- < 18 years of age
- •- Hemodynamic instability, respiratory failure, or Killip class >= 3 at time of
- •- 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 < 3 year
Investigators
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