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)

Recruiting

Conditions: Atherosclerosis
vulnerable plaque
10011082
10003216

Registration Number: NL-OMON48078

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 329

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<=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
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 < 3 year

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A composite of major adverse cardiovascular events (all-cause mortality,<br /><br>non-fatal myocardial infarction (STEMI or NSTEMI), or unplanned<br /><br>revascularization) at 2 year follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The primary outcome at 1 and 5 year follow-up. Also target lesion/vessel<br /><br>failure and target lesion/vessel revascularisation at 1,2, and 5 years. </p><br>