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TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons
The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions. Participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.
Patients at coronary angiography who are deemed suitable for PCI are assessed for eligibility. Patients fulfilling all inclusion and no exclusion criteria can be consented for trial participation. After successful lesion preparation, defined as residual stenosis less than 30%, TIMI flow 3 and no major (type C) dissection of target lesion, consented patients will be randomized in a 1:1 ratio to a drug eluting balloon(DEB)-based or standard drug eluting stent(DES)-based strategy and further randomized in a 1:1 fashion, stratified based on DEB vs DES, to undergo invasive follow-up at 6 (±30 days) or 12 (±30 days) months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Marco Valgimigli
Lugano, Switzerland
Start Date
February 21, 2023
Primary Completion Date
June 1, 2026
Completion Date
December 1, 2030
Last Updated
September 8, 2023
130
ESTIMATED participants
Magic Touch drug eluting balloon based strategy
DEVICE
Drug-eluting stent-based strategy
DEVICE
Lead Sponsor
Cardiocentro Ticino
Collaborators
NCT07195149
NCT07291609
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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