NCT05674630

Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Cardiocentro Ticino · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	Magic Touch drug eluting balloon based strategy	Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the experimental arm will receive treatment with drug eluting balloon (Magic Touch®) followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.
DEVICE	Drug-eluting stent-based strategy	Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the control arm will receive treatment with drug-eluting stent followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.

Timeline

• Start date: 2023-02-21
• Primary completion: 2026-06-01
• Completion: 2030-12-01
• First posted: 2023-01-06
• Last updated: 2023-09-08

Locations

1 site across 1 country: Switzerland