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Coronary Artery Healing and Bioresorbable Scaffold (HONEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03016624
Recruitment Status : Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : October 11, 2019
Information provided by (Responsible Party):
Christian Oliver Fallesen, Odense University Hospital

Brief Summary:
To compare coronary healing after optical coherence tomography guided versus conventionally angiography guided percutaneous coronary intervention with the Magmaris bioresorbable scaffold.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Coronary Artery Disease Device: OCT guided PCI Device: Angiography guided PCI Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : August 29, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: OCT guided Magmaris implantation
Percutaneous coronary intervention with Magmaris
Device: OCT guided PCI
oct guided

Active Comparator: Angiography guided Magmaris implantation
Percutaneous coronary intervention with Magmaris
Device: Angiography guided PCI
angio guided

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Coronary artery healing [ Time Frame: 6 and 12 months. ]
    Secondary endpoints are all individual components of coronary artery healing score

  2. Coronary artery healing [ Time Frame: 6 months ]
    Vasomotion at 6 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 risk.
  • Lesion length > 28 mm.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03016624

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Odense University Hospital
Odense, Region Of Southern Denmark, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
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Study Chair: Lisette O Jensen, MD, DMSci, PhD, Professor Odense University Hospital
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Responsible Party: Christian Oliver Fallesen, MD, PhD student, Odense University Hospital Identifier: NCT03016624    
Other Study ID Numbers: S-20150133
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases