Chronic Coronary Syndrome
Conditions
Keywords
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
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.
Detailed description
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.
Interventions
DEVICEMagic Touch drug eluting balloon based strategy
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.
DEVICEDrug-eluting stent-based strategy
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.
Sponsors
University of Bern
Cardiocentro Ticino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \<1 year due to other severe non-cardiac disease 8. Legally incompetent to provide informed consent 9. Participation in another clinical study with an investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change of FFR values (ΔFFR) | At 6(±30days) or 12(±30 days) months after the index PCI | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QCA parameter (maximal diameter stenosis, MaxS, percent) before and 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 | Maximal diameter stenosis (MaxS, percent) before the intervention, immediately after the intervention and at follow-up angiography. |
| QCA parameter (reference vessel diameter, RVD, mm) before and 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 | Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow-up angiography. |
| QCA parameter (lesion length, LL, mm) before and 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 | Lesion length (LL, mm) before the intervention, immediately after the intervention and at follow-up angiography. |
| QFR parameters before and after 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 | Quantitative Flow Ratio (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography |
| FFR parameters before and after 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 | Fractional Flow Reserve (FFR) parameters before the intervention, immediately after the intervention and at follow-up angiography |
| Minimal lumen diameter (MLD, mm) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | Minimal lumen diameter (MLD, mm) evaluated with intravascular ultrasound (IVUS) |
| Minimal luminal area (MLA, mm^2) | 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) evaluated with intravascular ultrasound (IVUS) |
| Maximal diameter stenosis (MaxS, percent) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | Maximal diameter stenosis (MaxS, percent) evaluated with intravascular ultrasound (IVUS) |
| Lumen volume (LV, mm^3) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | Lumen volume (LV, mm\^3) evaluated with intravascular ultrasound (IVUS) |
| Vessel volume (VV, mm^3) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | Vessel volume (VV, mm\^3) evaluated with intravascular ultrasound (IVUS) |
| QCA parameter (minimal lumen diameter, MLD, mm) before and 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) before the intervention, immediately after the intervention and at follow-up angiography. |
| Late lumen loss (LLL) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | Late lumen loss (LLL) evaluated with intravascular ultrasound (IVUS) |
| Acute gain | pre procedure and immediately after the procedure | Variation between pre treatment (T0) and immediately after the treatment (Tf) |
| Disease progression after index PCI | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the 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) |
| Target lesion revascularization (TLR) defined as urgent and non-urgent | 5 years after the index PCI | Rate of target lesion revascularization (TLR) defined as urgent and non-urgent |
| Target vessel revascularization (TVR), defined as urgent and non-urgent | 5 years after the index PCI | Rate of target vessel revascularization (TVR), defined as urgent and non-urgent |
| Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization | 5 years after the index PCI | Rate of target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization |
| 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 | 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) |
| Any myocardial infarction | 5 years after the index PCI | Rate of any myocardial infarction |
| Stroke | 5 years after the index PCI | Rate of stroke |
| Definite or probable stent thrombosis | 5 years after the index PCI | Rate of definite or probable stent thrombosis |
| Plaque burden (VV-LV) | pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI | Plaque burden (VV-LV) evaluated with intravascular ultrasound (IVUS) |
Countries
Switzerland
Contacts
Primary ContactMarco Valgimigli, M.D., Ph.D
Backup ContactEnrico Frigoli, M.D.
Outcome results
None listed