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Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

NCT05674630 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-09-08

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions.

Participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.

Conditions

  • Chronic Coronary Syndrome

Interventions

DEVICE

Magic Touch drug eluting balloon based strategy

Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the experimental arm will receive treatment with drug eluting balloon (Magic Touch®) followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.

DEVICE

Drug-eluting stent-based strategy

Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the control arm will receive treatment with drug-eluting stent followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER

  • Cardiocentro Ticino

    lead OTHER

Principal Investigators

  • Marco Valgimigli, M.D., Ph.D · Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2026-06-01
Completion
2030-12-01

Countries

  • Switzerland

Study Locations

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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 NCT05674630 on ClinicalTrials.gov