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Coronary Artery Healing and Bioresorbable Scaffold (HONEST)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Christian Oliver Fallesen, Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Christian Oliver Fallesen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT03016624
First received: January 9, 2017
Last updated: May 24, 2017
Last verified: May 2017
  Purpose
To compare coronary healing after optical coherence tomography guided versus conventionally angiography guided percutaneous coronary intervention with the Magmaris bioresorbable scaffold.

Condition Intervention
Myocardial Infarction Coronary Artery Disease Device: OCT guided PCI Device: Angiography guided PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Christian Oliver Fallesen, Odense University Hospital:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 90
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

BACKGROUND:

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.

AIM:

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.

METHOD:

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.

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03016624

Contacts
Contact: Christian O Fallesen, MD +45 52525191 cofallesen@yahoo.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Region of Southern Denmark, Denmark, 5000
Contact: christian o fallesen    52525191    christian.fallesen@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Investigators
Study Chair: Lisette O Jensen, MD, DMSci, PhD, Professor Odense University Hospital
  More Information

Responsible Party: Christian Oliver Fallesen, MD, PhD student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03016624     History of Changes
Other Study ID Numbers: S-20150133
Study First Received: January 9, 2017
Last Updated: May 24, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Infarction
Myocardial Ischemia
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 21, 2017