MedTrace Logo

Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II

NCT04893291 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1820

Last updated 2026-02-19

No results posted yet for this study

Summary

International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).

Conditions

Interventions

DEVICE

Everolimus Eluting Stent

Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care

DEVICE

Sirolimus Coated Balloon

Patients assigned to this Arm will be treated with Magic Touch Drug Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care

Sponsors & Collaborators

  • Fondazione Ricerca e Innovazione Cardiovascolare ETS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2026-08-30
Completion
2030-08-30

Countries

  • Bangladesh
  • Brazil
  • Brunei
  • France
  • Italy
  • Malaysia
  • Netherlands
  • Poland
  • Spain
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

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 NCT04893291 on ClinicalTrials.gov