|- candidate number||23469|
|- NTR Number||NTR5590|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-dec-2015|
|- Secondary IDs||NL55011.029.15 METc VUMC |
|- Public Title||Pre-emptive, OCT guided angioplasty of vulnerable, intermediate coronary lesions: a randomized trial, the ‘PECTUS’ Trial|
|- Scientific Title||Pre-emptive, OCT guided angioplasty of vulnerable, intermediate coronary lesions: a randomized trial, the ‘PECTUS’ Trial|
|- hypothesis||Stenting with a bioabsorbable vascular scaffold of intermediate, vulnerable coronary lesions in patients with residual non-obstructive CAD after myocardial infarction will prevent future Major Adverse Cardiac Events (MACE)|
|- Healt Condition(s) or Problem(s) studied||Coronary artery disease, Coronary atherosclerosis|
|- 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||· Refusal or inability to provide informed consent.
· < 18 years of age
· Previous CABG.
· Indication for revascularization by CABG.
· Target vessel diameter < 2,5 mm or >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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||4-mrt-2016|
|- planned closingdate||1-mrt-2023|
|- Target number of participants||500|
|- 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 placement or to conservative (optimal medical) therapy.|
|- Primary outcome||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 outcome||The same composite at 2 and 5 years|
|- Timepoints||1, 2 and 5 years|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. Niels Royen, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Niels Royen, van|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Abbott Vascular, St. Jude Medical|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||8-dec-2015 - 22-mei-2016|