Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons
ConditionChronic Coronary Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardiocentro Ticino
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Patients referred to the index procedure for an acute coronary syndrome
Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery
Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment
Spontaneous coronary artery dissection (SCAD)
Trial design
Treatments tested in this trial
- Magic Touch drug eluting balloon based strategy
- Drug-eluting stent-based strategy
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Cardiocentro Ticino
Lead sponsor
University of Bern
Collaborator
Source ClinicalTrials.gov