Coronary Disease
Conditions
Keywords
Coronary disease, Bifurcation lesion
Brief summary
KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection
Detailed description
In the treatment of bifurcation lesion, the role of side branch intervention for improving the safety of Percutaneous Coronary Intervention (PCI), when MB is treated according to the Murray law with a Proximal Optimization Technique (POT), remains unclear. The KISS study will evaluate the non-inferiority of no side branch intervention versus side branch ballooning, in the setting of single stenting with systematic proximal optimization technique.
Interventions
PROCEDURESide branch protection/ballooning
Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
PROCEDURENo side branch protection/ballooning
No intervention on the side branch
Sponsors
Ceric Sàrl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Coronary artery disease requiring revascularization that is amenable to percutaneous coronary intervention (PCI) 2. Any de novo Medina type bifurcation lesion with \>70% lesion in the main vessel by visual assessment except Medina 0,0,1 if the planned strategy does not include a main branch stenting 3. Side branch diameter compatible with a PCI with stent implantation (≥ 2.25mm) 4. Side branch requiring a protection wire according to operator evaluation 5. Anatomy compatible with a proximal optimization technique 6. Post main branch treatment (stenting then POT): Absence of side branch occlusion Or low flow associated with ongoing ischemia (either chest pain or ST changes) 7. Male or female patient \>18 years old
Exclusion criteria
1. Acute myocardial infarction with ongoing ST-elevation 2. Cardiogenic shock 3. Requirement for ongoing hemodialysis 4. Life-expectancy limited to \<12 months due to co-morbid condition 5. Lesion involves the left main coronary artery 6. Lesion requiring a double stenting 7. Plan to treat \>1 other coronary vessel at the time of the index procedure 8. Two lesions treated in the same session: unsuccessful PCI on the single non bifurcation lesion in a non-target vessel before the treatment of the target lesion. 9. Chronic total occlusion of any target vessel 10. Left ventricular ejection fraction \<20% 11. Side branch TIMI Flow \<3 12. Pre-dilatation of the Side Branch during the procedure prior to randomization 13. Known allergy to Aspirin 14. Known allergy to Clopidorel and Prasugrel and Ticagrelor 15. Known allergy to stent drug elutant 16. Known allergy to any other component of Onyx Resolute stent 17. Ongoing participation in another investigational device or drug study 18. Inability to provide informed consent 19. Patients under judicial protection, tutorship or curatorship 20. Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural Myocardial infarction | up to 48 hours post-procedure, up to 12 months | Rate of peri-procedural Myocardial Infarction (MI) at discharge or 48 hours post-procedure whichever comes first as judged by clinical evaluation in association with day-1 troponin evaluation using the ARC-2 definition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success (2) | Intraoperative, up to 12 months | Total procedure time |
| Technical success (3) | up to 12 months | Acute gain in main and side branches as measured with a dedicated quantitative coronary analysis (QCA) software |
| Technical success (4) | Intraoperative, up to 12 months | Fluoroscopy time |
| Technical success (5) | Intraoperative, up to 12 months | Total radiation dose (air kerma) |
| Technical success (1) | Intraoperative, up to 12 months | Deployment of main branch (MB) stent with \<20% residual stenosis and a patent side branch at end of procedure upon corelab analysis |
| Target Lesion Failure (TLF) | 1 month and 12 months | Composite of: * Cardiac Death * Target vessel Myocardial Infarction * Clinically driven Target lesion revascularization (ci-TLR) |
| Target Lesion Revascularization (TLR) | 1 month and 12 months | Main Branch & Side Branch TLR |
| Stent thrombosis: | 1 month and 12 months | Definite or Probable stent thrombosis (ARC-2 criteria) |
| Angina status | 1 month and 12 months | Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4) |
| Technical success (6) | Intraoperative, up to 12 months | Total contrast dose |
Countries
France, Italy, Portugal, Spain, Switzerland, United Kingdom
Outcome results
None listed