No registrations found.
ID
Source
Brief title
Health condition
Coronary artery disease; vulnerable plaque
Sponsors and support
Intervention
Outcome measures
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
Study objective
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)
Study design
1, 2 and 5 years
Intervention
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.
de Boelelaan 1117
Niels Royen, van
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442244
n.vanroyen@vumc.nl
de Boelelaan 1117
Niels Royen, van
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442244
n.vanroyen@vumc.nl
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.
· Pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4177 |
| NTR-old | NTR5590 |
| CCMO | NL55011.029.15 |
| OMON | NL-OMON43561 |