TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI
• At least one significant de-novo coronary lesion (defined as diameter stenosis \> 50% on angiography, with flow limiting features, confirmed with FFR ≤0.80 or iFR ≤0.89 and intended implantation of a long (≥30 mm) DES based on IVUS findings
• Written informed consent
Locations
Other Locations
Switzerland
Marco Valgimigli
RECRUITING
Lugano
Contact Information
Primary
Marco Valgimigli, M.D., Ph.D
marco.valgimigli@eoc.ch
+410918115111
Backup
Enrico Frigoli, M.D.
enrico.frigoli@eoc.ch
Time Frame
Start Date: 2023-02-21
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 130
Treatments
Experimental: Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up
Patients randomized to DEB-based strategy will receive treatment with DEB (Magic Touch, Concept Medical®) throughout the entire lesion length, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion.
Active_comparator: Drug eluting stent based strategy - 6/12 months invasive follow up
Percutaneous transluminal coronary angioplasty and drug eluting stent implantation according to local standard of care, including optimization techniques (e.g. post-dilatation) which are left at operators' discretion, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion.
Related Therapeutic Areas
Sponsors
Leads: Cardiocentro Ticino
Collaborators: University of Bern