NCT05674630 Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons
| NCT ID | NCT05674630 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cardiocentro Ticino |
| Condition | Chronic Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-02-21 |
| Primary Completion | 2026-06-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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: 1. Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI 2. 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 3. Written informed consent Exclusion Criteria: 1. Patients referred to the index procedure for an acute coronary syndrome 2. Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery 3. Severe renal impairment (eGFR\<15ml/min/1.73m2) or patient on dialysis treatment 4. Spontaneous coronary artery dissection (SCAD) 5. 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) 6. Known pregnancy or breast-feeding patients 7. Life expectancy