Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis

NCT04666584 | Unknown

• 2 other identifiers: Odense University HospitalS-20200114
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate if lesion preparation with a ScoreFlex balloon compared to a standard non-compliant balloon improve vascular healing and minimize lumen reduction after implantation of a Magmaris bioresorbable scaffold.

Conditions

Coronary Artery Disease; Stable Angina; Coronary Artery Stenosis; Myocardial Infarction; Cardiovascular Diseases; Myocardial Ischemia; Atherosclerosis of Artery; Coronary Disease; Heart Diseases; Arterial Occlusive Diseases

Keywords

bioresorbable scaffolds; optical coherence tomography; intravascular ultrasound; modified balloons

Outcome Measures

Primary Outcomes (1)

• Minimal Lumen Area

  Minimal Lumen Area

  6 months after index percutaneous coronary intervention

Secondary Outcomes (4)

• Change in remodeling Index

  6 months and 12 months after index percutaneous coronary intervention

• Change in Minimal Lumen Area

  6 months and 12 months after index percutaneous coronary intervention

• Percentage of incomplete scaffold apposition

  6 months and 12 months after index percutaneous coronary intervention

• Percentage of uncovered struts

  6 months and 12 months after index percutaneous coronary intervention

Study Arms (2)

ScoreFlex balloon

ACTIVE COMPARATOR

Pre-dilatation with a ScoreFlex balloon before implantation with a Magmaris bioresorbable scaffold

Device: ScoreFlex balloon

Standard non-compliant balloon

ACTIVE COMPARATOR

Pre-dilatation with a non-compliant balloon before implantation with a Magmaris bioresorbable scaffold

Device: Device: standard non-compliant balloon

Interventions

ScoreFlex balloon DEVICE

Pre-dilatation with a ScoreFlex balloon

ScoreFlex balloon

Device: standard non-compliant balloon DEVICE

Pre-dilatation with a standard non-compliant balloon

Standard non-compliant balloon

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 stable angina pectoris and non-ST elevation myocardial infarction referred for invasive coronary angiography and percutaneous coronary intervention at Department of Cardiology, Odense University Hospital (Odense, Denmark)

You may not qualify if:

• participation in other randomized clinical trials
• life expectancy \< 1 year
• allergy to aspirin, clopidogrel, ticagrelor or prasugrel
• eGFR \< 30 mL/min
• tortuous and angiographically estimated extremely calcified lesions
• ostial, left main and bifurcation lesions
• lesions in a reference vessel diameter \< 2.0 mm
• hemodynamic instability
• scheduled for coronary artery bypass grafting

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

• Hansen KN, Maehara A, Troan J, Noori M, Hougaard M, Ellert-Gregersen J, Veien KT, Junker A, Hansen HS, Lassen JF, Jensen LO. Mechanistic insights into lumen reduction after implantation of a drug-eluting bioresorbable metallic scaffold assessed with serial intracoronary imaging: from the OPTIMIS trial. Coron Artery Dis. 2026 Mar 1;37(2):84-94. doi: 10.1097/MCA.0000000000001561. Epub 2025 Aug 20.

  PMID: 40832681 DERIVED

• Hansen KN, Troan J, Maehara A, Noori M, Hougaard M, Ellert-Gregersen J, Veien KT, Junker A, Hansen HS, Lassen JF, Jensen LO. Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis: The OPTIMIS Trial. Circ Cardiovasc Interv. 2025 Jan;18(1):e014665. doi: 10.1161/CIRCINTERVENTIONS.124.014665. Epub 2025 Jan 21.

  PMID: 39836741 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Coronary Stenosis; Myocardial Infarction; Cardiovascular Diseases; Myocardial Ischemia; Coronary Disease; Heart Diseases; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Lisette O. Jensen, MD PhD Prof

  Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Offline data analysis will be performed without knowing the allocated intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible patients randomized to predilatation with ScoreFlex balloon or a standard non-compliant balloon before percutaneous coronary intervention with implantation of a Magmaris bioresorbable scaffold.

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 14, 2020
• Study Start: December 14, 2020
• Primary Completion: March 8, 2024
• Study Completion: December 31, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)