Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons (TITAN-DEB)
Chronic Coronary Syndrome
About this trial
This is an interventional treatment trial for Chronic Coronary Syndrome focused on measuring adult, chronic coronary syndrome, percutaneous intervention, significant de novo coronary lesion, FFR≤0.80, iFR≤0.89, long DES (≥30 mm), coronary lesion, drug eluting balloon, drug eluting stent, Magic Touch drug eluting balloon
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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 patients Life expectancy <1 year due to other severe non-cardiac disease Legally incompetent to provide informed consent Participation in another clinical study with an investigational product
Sites / Locations
- Marco ValgimigliRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up
Drug eluting stent 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.
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.