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.
ID: Study Details | NCT04285372 | Keep bIfurcation Single Stenting Simple | ClinicalTrials.gov
Sponsor
Sponsors
Primary endpoints
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
CERC Services
- Project management
- Set-up activities (sites selection, insurance management, contract management)
- Regulatory submissions
- CRF and Data management
- Monitoring activities
- Clinical Events Committee (CEC) activities
- CoreLab activities
- Statistical Analysis
- Clinical report
Countries
France, Italy, Portugal, Spain, Switzerland, United Kingdom
Number of investigational sites
20 sites
Number of patients
596
