KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation percutaneous coronary intervention (PCI) procedures for side branch protection.
In the treatment of bifurcation lesion, the role of side branch intervention for improving the safety of Percutaneous Coronary Intervention (PCI), when main branch 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.
Rate of peri-procedural Myocardial Infarction (MI) at discharge or 48h post-procedure whichever comes first as judged by clinical evaluation in association with day-1 troponin evaluation using the ARC-2 definition
- General study management
- Set-up activities,
- Clinical trial documentation,
- Regulatory submissions,
- eCRF / data-management,
- CEC activities,
- CoreLab activities,
- Statistical analysis,
- Clinical report
- United Kingdom
- Up to 20 sites