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NCT05674630
Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons
Conditions: Chronic Coronary Syndrome
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 130
Sponsor: Cardiocentro Ticino
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 Criteria
Inclusion Criteria:Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCIAt 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 findingsWritten informed consentExclusion Criteria:Patients referred to the index procedure for an acute coronary syndromeTarget lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary arterySevere renal impairment (eGFR<15ml/min/1.73m2)
or patient on dialysis treatmentSpontaneous coronary artery dissection (SCAD)Contraindications to adenosine administration (e.g.
moderate to severe asthma or chronic obstructive pulmonary disease, heart rate <50 beats/min and systolic blood pressure <90 mmHg)Known pregnancy or breast-feeding patientsLife expectancy <1 year due to other severe non-cardiac diseaseLegally incompetent to provide informed consentParticipation in another clinical study with an investigational product
Source: ClinicalTrials.gov (NCT05674630). StuddyBuddy aggregates publicly available trial information.