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)
ID
Bron
Verkorte titel
Aandoening
Coronary artery disease; vulnerable plaque
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Doel van het onderzoek
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)
Onderzoeksopzet
1, 2 and 5 years
Onderzoeksproduct en/of interventie
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.
Publiek
de Boelelaan 1117
Niels Royen, van
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442244
n.vanroyen@vumc.nl
Wetenschappelijk
de Boelelaan 1117
Niels Royen, van
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442244
n.vanroyen@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
· 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
· 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4177 |
| NTR-old | NTR5590 |
| CCMO | NL55011.029.15 |
| OMON | NL-OMON43561 |