Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

Study Overview
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Brief Summary
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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
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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.

Official Title
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TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons

Conditions
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Chronic Coronary Syndrome

Intervention / Treatment
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* Device: Magic Touch drug eluting balloon based strategy
* Device: Drug-eluting stent-based strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up<br>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. | Device: Magic Touch drug eluting balloon based strategy<br>* 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.<br>|
| Active Comparator: Drug eluting stent based strategy - 6/12 months invasive follow up<br>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. | Device: Drug-eluting stent-based strategy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change of FFR values (ΔFFR) | Absolute change of fractional flow reserve (FFR) values (ΔFFR) measured at the final assessment immediately after the index PCI and invasive follow-up at 6(±30days) or 12(±30 days) months | At 6(±30days) or 12(±30 days) months after the index PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography | Minimal lumen diameter (MLD,mm) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography | Maximal diameter stenosis (MaxS, percent) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography | Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography. | Lesion length (LL, mm) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| QFR parameters before and after intervention and at follow-up angiography | Quantitative Flow Ratio (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| FFR parameters before and after intervention and at follow-up angiography | Fractional Flow Reserve (FFR) parameters before the intervention, immediately after the intervention and at follow-up angiography | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| Minimal lumen diameter (MLD, mm) | Minimal lumen diameter (MLD, mm) evaluated with intravascular ultrasound (IVUS) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| Minimal luminal area (MLA, mm^2) | Minimal luminal area (MLA, mm^2) evaluated with intravascular ultrasound (IVUS) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| Maximal diameter stenosis (MaxS, percent) | Maximal diameter stenosis (MaxS, percent) evaluated with intravascular ultrasound (IVUS) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| Lumen volume (LV, mm^3) | Lumen volume (LV, mm^3) evaluated with intravascular ultrasound (IVUS) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| Vessel volume (VV, mm^3) | Vessel volume (VV, mm^3) evaluated with intravascular ultrasound (IVUS) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| Plaque burden (VV-LV) | Plaque burden (VV-LV) evaluated with intravascular ultrasound (IVUS) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| Late lumen loss (LLL) | Late lumen loss (LLL) evaluated with intravascular ultrasound (IVUS) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| Acute gain | Variation between pre treatment (T0) and immediately after the treatment (Tf) | pre procedure and immediately after the procedure | 
| Disease progression after index PCI | Variation between final result of index PCI (Tf) and procedure at 6(±30days) or 12(±30 days) months after the index PCI (Tc) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | 
| Target lesion revascularization (TLR) defined as urgent and non-urgent | Rate of target lesion revascularization (TLR) defined as urgent and non-urgent | 5 years after the index PCI | 
| Target vessel revascularization (TVR), defined as urgent and non-urgent | Rate of target vessel revascularization (TVR), defined as urgent and non-urgent | 5 years after the index PCI | 
| Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization | Rate of target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization | 5 years after the index PCI | 
| The individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization) | Rate of the individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization) | 5 years after the index PCI | 
| Any myocardial infarction | Rate of any myocardial infarction | 5 years after the index PCI | 
| Stroke | Rate of stroke | 5 years after the index PCI | 
| Definite or probable stent thrombosis | Rate of definite or probable stent thrombosis | 5 years after the index PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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