NCT04893291

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,820 (estimated)
• Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of TRANSFORM II study is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting Drug Eluting Stent (DES). Given the inherent and recognized limitations of stents in native vessels with diameter \<3 mm, only patients with coronary vessels up to 3.5 mm of diameter (by visual estimation) will be enrolled in this study.

Conditions

• Coronary Artery Disease
• Coronary Artery Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-16
• Primary completion: 2026-08-30
• Completion: 2030-08-30
• First posted: 2021-05-19
• Last updated: 2026-02-19

Locations

53 sites across 11 countries: Bangladesh, Brazil, Brunei, France, Italy, Malaysia, Netherlands, Poland, Spain, Thailand, United Kingdom