Coronary Artery Healing and Bioresorbable Scaffold

NCT ID: NCT03016624

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2024-09-30

Brief Summary

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

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.

Conditions

Myocardial Infarction; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OCT guided Magmaris implantation

Percutaneous coronary intervention with Magmaris

Group Type: ACTIVE_COMPARATOR

OCT guided PCI

Intervention Type: DEVICE

oct guided

Angiography guided Magmaris implantation

Percutaneous coronary intervention with Magmaris

Group Type: ACTIVE_COMPARATOR

Angiography guided PCI

Intervention Type: DEVICE

angio guided

Interventions

OCT guided PCI

oct guided

Intervention Type: DEVICE

Angiography guided PCI

angio guided

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christian Oliver Fallesen

MD, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisette O Jensen, MD, DMSci, PhD, Professor

Role: STUDY_CHAIR

Odense University Hospital

Locations

Odense University Hospital

Odense, Region Syddanmark, Denmark

Countries

Denmark

References

Fallesen CO, Antonsen L, Maehara A, Noori M, Hougaard M, Hansen KN, Ellert J, Ahlehoff O, Veien KT, Lassen JF, Junker AB, Hansen HS, Jensen LO. Optical Coherence Tomography- Versus Angiography-Guided Magnesium Bioresorbable Scaffold Implantation in NSTEMI Patients. Cardiovasc Revasc Med. 2022 Jul;40:101-110. doi: 10.1016/j.carrev.2021.12.003. Epub 2021 Dec 15.

Reference Type: DERIVED

PMID: 34949544 (View on PubMed)

Other Identifiers

S-20150133

Identifier Type: -

Identifier Source: org_study_id