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Pre-emptive, OCT guided angioplasty of vulnerable, intermediate coronary lesions: a randomized trial, the ‘PECTUS’ Trial

Pre-emptive, OCT guided angioplasty of vulnerable, intermediate coronary lesions: a randomized trial, the ‘PECTUS’ Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26010
Enrollment
500
Registered
2015-12-08
Start date
2016-03-04
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Coronary artery disease

Interventions

After inclusion, patients will undergo coronary CT and OCT to determine if the residual stenosis is vulnerable. In case of vulnerable plaques at OCT, patients will be randomized to PCI with BVS placem

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: · Informed consent must be obtained · Patients with STEMI or NSTEMI and residual, non-obstructive CAD, with the possibility of plaque vulnerability. · The coronary lesion must be suitable for PCI with a commercially available BVS.

Exclusion criteria

Exclusion criteria: · Refusal or inability to provide informed consent. · 4.0 mm · Anatomy or lesions unsuitable for OCT catheter crossing or imaging (aorta-ostial lesions, small diameter segment, severe calcifications) · Anatomy unsuitable for BVS placement (left main, bifurcation stenting, sidebranch (> 2 mm) involvement). · Target lesion is instent restenosis · Target lesion is chronic total occlusion · Severe kidney disease defined as an eGFR < 30 ml/min. · Pregnancy.

Design outcomes

Primary

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

Secondary

MeasureTime frame
The same composite at 2 and 5 years

Contacts

Public ContactNiels Royen, van

Department of Cardiology, VU University de Boelelaan 1117

n.vanroyen@vumc.nl+31 (0)20 4442244

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)