Coronary Artery Healing and Bioresorbable Scaffold (HONEST)
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|ClinicalTrials.gov Identifier: NCT03016624|
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Coronary Artery Disease||Device: OCT guided PCI Device: Angiography guided PCI||Not Applicable|
Bioresorbable scaffolds (BRS) represent a novel approach during percutaneous coronary intervention (PCI), which provides transient vessel support with drug-delivery capability without the long-term limitations (very late stent thrombosis) of the metallic drug-eluting stents. Patients with Non-ST-segment elevation myocardial infarction (NSTEMI) often feature thrombus-rich lesions with large necrotic core, which may be associated with delayed arterial healing and impaired stent-related outcomes. Besides clinical indication and underlying plaque morphology, sufficient and potent strut coverage depends on several additional factors (patient characteristics, stent type and procedural factors). Particularly, acute incomplete stent apposition is a strong procedural risk factor for later deficient neointimal coverage. Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality, that enables in-vivo evaluation of the immediate stenting result, and the vascular healing pattern including strut coverage at follow-up.
The objective of this study is to investigate if OCT-guided Magmaris BRS implantation in patients with NSTEMI can improve the coronary arterial healing at 6 months compared to routine angiographic guidance only. Further to investigate if the plaque composition/lipid content will influence on the vascular healing.
The study is designed as a prospective, randomized trial. After pre-dilation, patients will be randomly assigned to either: (1) OCT-guided PCI, or (2) angio-guided PCI with Magmaris BRS implantation. In the OCT-guided group, OCT will be used for vessel and BRS sizing. After Magmaris BRS implantation the result will be controlled with OCT and: 1) BRS under expansion and/or, 2) strut malapposition and/or, 3) edge dissection- and/or 4) residual stenosis at the distal and/or proximal reference segment(s) that may require further intervention. A final OCT will be performed in case of re-intervention.
In the angio-guided group an OCT will be performed only after angiography final and acceptable result.
A follow-up OCT will be performed after 6 months in all patients to assess the vascular healing and a vasomotor test will be performed in half of the patients. After 12 months the dynamic changes in vascular healing will be assessed in the first enrolled half of the patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Coronary Artery Healing Process After BiOresorbable Scaffold iN PatiEnts With Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Active Comparator: OCT guided Magmaris implantation
Percutaneous coronary intervention with Magmaris
Device: OCT guided PCI
Active Comparator: Angiography guided Magmaris implantation
Percutaneous coronary intervention with Magmaris
Device: Angiography guided PCI
- Coronary artery healing score [ Time Frame: 6 months ]The primary endpoint is coronary artery healing score assessed by OCT Healing score is a weighted index that combines the following components: Uncovered scaffold struts, Uncovered "jailed" and acquired or persistent malapposed struts, Persistent mal apposition, Acquired mal apposition, Maximum neointimal growth and Accumulated extra stent lumen
- Coronary artery healing [ Time Frame: 6 and 12 months. ]Secondary endpoints are all individual components of coronary artery healing score
- Coronary artery healing [ Time Frame: 6 months ]Vasomotion at 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016624
|Contact: Christian O Fallesen, MD||+45 email@example.com|
|Odense University Hospital||Recruiting|
|Odense, Region of Southern Denmark, Denmark, 5000|
|Contact: christian o fallesen 52525191 firstname.lastname@example.org|
|Study Chair:||Lisette O Jensen, MD, DMSci, PhD, Professor||Odense University Hospital|