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

Study acronym: TRANSFORM II
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 19, 2026 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study title expanded, about 3 wordsv10
  2. Primary completion date: Nov 30, 2025 to Aug 30, 2026
    • Study completion date: Nov 30, 2028 to Aug 30, 2030
    v9
  3. Primary completion date: Nov 30, 2024 to Nov 30, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 25 to 53
    v8
  4. Re-verified, no change to tracked fieldsv7
  5. Enrollment target: 1325 to 1820
    • Study sites: 10 to 25
    • Eligibility criteria expanded, about 7 words
    • Study description revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 3 to 10v5
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 3
    • Primary completion date: Oct 30, 2024 to Nov 30, 2024
    • Study completion date: Oct 30, 2028 to Nov 30, 2028
    • Start date changed from estimate of Oct 30, 2021 to Nov 16, 2021
  3. Enrollment target: 1130 to 1325v3
  4. Start date: Jun 30, 2021 to Oct 30, 2021
    • Primary completion date: Jun 30, 2024 to Oct 30, 2024
    • Study completion date: Jun 30, 2028 to Oct 30, 2028
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04893291
Lead Sponsor Fondazione Ricerca e Innovazione Cardiovascolare ETS
Conditions
(from sponsor)		 Coronary Artery Disease, Coronary Artery Stenosis
Related terms Coronary Artery Disease, Coronary Stenosis
Enrollment 1,820 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov