AnGiographic Performance With A Sirolimus-elutiNG Balloon in the TrEatment of De Novo CoronaRy Artery Disease

Not Applicable

Recruiting

• Conditions: Coronary Restenosis
• Interventions: Device: Magic Touch SCB by Concept Medical Inc.

• Registration Number: NCT05471245
• Lead Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

Brief Summary

Evaluate angiographic performance in long lesions of Sirolimus Eluting Balloon Magic Touch by Concept Medical

Detailed Description

To assess the angiographic performance of the Magic Touch Sirolimus-Coated Balloon (SCB) at 9 months follow-up after PCI for de novo CAD.

Primary end-points:

* Late lumen loss (LLL) at the SCB-treated segment within 9 months after the index procedure;

* Mean net lumen diameter gain at the SCB-treated segment at 9 months angiographic follow-up.

Secondary end-points:

* Procedural success defined as both SCB delivery and inflation at the "target" lesion site with \<30% diameter stenosis (DS) in the SCB-treated segment and distal Thrombolysis In Myocardial Infarction (TIMI) 3 flow;

* Peri-procedural myocardial infarction (PMI) defined according to the EXCEL trial (creatinine kinase myocardial band) or Society for Cardiovascular Angiography and Interventions definitions (troponin);

* Binary restenosis rate at the SCB-treated segment at 9 months angiographic follow-up;

* A Device Oriented Composite End-point (DOCE) and its singular components (cardiac death, any target-vessel myocardial infarction excluding PMI, ischemia-driven target lesion revascularization) in-hospital, within 7 days after PCI; phone follow-up at 30-day (+/- 7 days) and 12 months (+/- 1 month) and a follow-up visit at 9 months (+/- 1 month). Any definite/probable SCB-treated segment thrombosis (in-hospital, within 7 days after PCI and at 30-day, 9-month, 1-year follow-up).

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Study Start: 2023-05-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
angiographic evaluation	Magic Touch SCB by Concept Medical Inc.	QCA at 9 months

Primary Outcome Measures

Name	Time	Method
late lumen loss at 9 months measured by quantitative coronary angiography	18 months	QCA by core lab
incidence of adverse clinical events	18 months	myocardial infarction, death, need for revascularization

Trial Locations

Locations (6)

AULSS 2 Marca Trevigiana Ospedale di Conegliano; 🇮🇹 Conegliano, Italy/TV, Italy

Policlinico Tor Vergata; 🇮🇹 Rome, Italy/RM, Italy

Centro Cardiologico Monzino; 🇮🇹 Milan, Italy/MI, Italy

IRCCS Ospedale Galeazzi Sant'Ambrogio; 🇮🇹 Milan, Italy/MI, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy/MI, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Udine, Italy/UD, Italy