To compare coronary healing after optical coherence tomography guided versus conventionally
angiography guided percutaneous coronary intervention with the Magmaris bioresorbable
Device: OCT guided PCI
Device: Angiography guided PCI
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Full eligibility criteria for NCT03016624
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patients with NSTEMI undergoing subacute PCI in native vessels and to be treated with
one or more drug eluting stents in coronary arteries due to a visually assessed
significant culprit lesion with > 50% of coronary stenosis at the catheterization
laboratory in Odense.
Patients participating in other randomized stent studies.
Expected survival < 1 year.
Allergy to aspirin, ticagrelor, clopidogrel and prasugrel.
Allergy to Sirolimus.
Aorta-ostial lesions (cannot be cleared with flush by OCT).
Serum creatinine > 150 ug/L due to the required amount of X-ray contrast by OCT.
Twisted coronary vessels where the PCI-operator estimates that the introduction of an
OCT and / or NIRS catheter will not be possible or will be associated with increased
Lesion length > 28 mm.
All locations for NCT03016624
Odense University Hospital
Odense, Region Of Southern Denmark, Denmark, 5000
View full eligibility
Tris trial is registered with FDA with number: NCT03016624. The sponsor of the trial is Odense University Hospital and it is looking for 75 volunteers for the current phase.
Official trial title: Coronary Artery Healing Process After BiOresorbable Scaffold iN PatiEnts With Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
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