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

NCT04666584 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-09-13

No results posted yet for this study

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

Interventions

DEVICE

ScoreFlex balloon

Pre-dilatation with a ScoreFlex balloon

DEVICE

Device: standard non-compliant balloon

Pre-dilatation with a standard non-compliant balloon

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Lisette O. Jensen, MD PhD Prof · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2024-03-08
Completion
2024-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04666584 on ClinicalTrials.gov