Clinical Trial

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

Study acronym: TRANSFORM II
Active, Not Recruiting
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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).
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-05-18; most recent amendment 2026-02-17.
Status change: Recruiting → Active, Not Recruiting 2025-10-01
Status change: Not Yet Recruiting → Recruiting 2021-12-22
Trial Details
NCT Number NCT04893291
Lead Sponsor Fondazione Ricerca e Innovazione Cardiovascolare ETS
Conditions Coronary Artery Disease, Coronary Artery Stenosis
Enrollment 1,820 participants
Start Date 2021-11-16
Primary Completion 2026-08-30 (estimated)
Study Completion 2030-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-19