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TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon

NCT03913832 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2022-10-05

No results posted yet for this study

Summary

The study is a prospective, multinational (Italy, Ireland and UK), multicenter, randomised Clinical Trial that compares the efficacy and performance of two drug coated balloon (DCB), the MAGIC TOUCH sirolimus coated balloon (Concept Medical) and SeQuent Please paclitaxel coated balloon (B Braun). The objective of the study is to compare angiographic outcomes of Magic TouchTM sirolimus coated balloon (Concept Medical) versus SeQuentTM paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in small vessels (≤2.75 mm) with respect to Net Gain (mm) at 6 months follow-up

Conditions

Interventions

DEVICE

sirolimus drug coated balloon (SCB)

Magic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and Nano based drug delivery technology. Magic Touch SCB is a product of CMI proprietary drug delivery technology "Nanolute". It is indicated (CE approved) for ISR, small vessels, bifurcation lesions \& de novo lesions.

DEVICE

paclitaxel releasing coronary balloon catheter

SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter.

Sponsors & Collaborators

  • Concept Medicals BV

    lead INDUSTRY

Principal Investigators

  • Patrick Serruys, Dr · NUIG Imaging CoreLab

  • Bernardo Cortese, Dr · Fondazione RIC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2023-03-10
Completion
2023-09-10

Countries

  • Ireland
  • Italy
  • 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 NCT03913832 on ClinicalTrials.gov