10.6084/m9.figshare.4970069.v1
Karjalainen P.
Karjalainen
P.
Paana T.
Paana
T.
Sia J.
Sia
J.
Nammas W.
Nammas
W.
Supplementary Material for: Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Absorbable Metal Scaffold Implantation in de novo Native Coronary Lesions: Rationale and Design of the Magmaris-OCT Study
Karger Publishers
2017
Optical coherence tomography
Absorbable metal scaffolds
Neointimal healing
2017-05-04 06:57:31
Journal contribution
https://karger.figshare.com/articles/journal_contribution/Supplementary_Material_for_Neointimal_Healing_Evaluated_by_Optical_Coherence_Tomography_after_Drug-Eluting_Absorbable_Metal_Scaffold_Implantation_in_de_novo_Native_Coronary_Lesions_Rationale_and_Design_of_the_Magmaris-OCT_Study/4970069
<p><b><i>Objectives:</i></b> We sought to explore neointimal healing
assessed by optical coherence tomography (OCT) following implantation of
the Magmaris sirolimus-eluting absorbable metal scaffold. <b><i>Methods:</i></b>
The Magmaris-OCT is a prospective, multicenter, single-arm
observational clinical study, intended to enrol 60 consecutive patients
with up to 2 de novo native coronary lesions, each located in different
major epicardial vessels, with a reference vessel diameter of 2.5-3.5
mm, and a maximum lesion length of 20 mm. Patients will undergo Magmaris
scaffold implantation in the target lesion, according to the standard
practice. Clinical follow-up will take place at 30 days, and at 3, 6, 9,
and 12 months. For invasive-imaging follow-up, patients will be
classified into 3 groups: cohort A will be scheduled for follow-up at 3
months, cohort B at 6 months, and cohort C at 12 months. Invasive
imaging will include quantitative coronary angiography, OCT evaluation,
and coronary flow reserve measurement. The primary end point will be the
percentage of uncovered scaffold struts assessed by OCT at the
prespecified follow-up. <b><i>Conclusions:</i></b> This study will
provide insight into the short- and mid-term healing properties
following Magmaris scaffold implantation, with special emphasis on the
neointimal coverage of scaffold struts.</p>