Coronary Artery Healing and Bioresorbable Scaffold

NCT03016624 | Unknown DMC

• 1 other identifier: S-20150133
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myocardial Infarction; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Coronary artery healing score

  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

  6 months

Secondary Outcomes (2)

• Coronary artery healing

  6 and 12 months.

• Coronary artery healing

  6 months

Study Arms (2)

OCT guided Magmaris implantation

ACTIVE COMPARATOR

Percutaneous coronary intervention with Magmaris

Device: OCT guided PCI

Angiography guided Magmaris implantation

ACTIVE COMPARATOR

Percutaneous coronary intervention with Magmaris

Device: Angiography guided PCI

Interventions

OCT guided PCI DEVICE

oct guided

OCT guided Magmaris implantation

Angiography guided PCI DEVICE

angio guided

Angiography guided Magmaris implantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34949544 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Lisette O Jensen, MD, DMSci, PhD, Professor

  Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 10, 2017
• Study Start: February 1, 2017
• Primary Completion: August 29, 2019
• Study Completion: September 1, 2024
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

DK (1)