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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
596
Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
No intervention on the side branch
CHU Caen
Caen, France
Hôpital Privé Dijon Bourgogne
Dijon, France
Periprocedural Myocardial infarction
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
Time frame: up to 48 hours post-procedure, up to 12 months
Technical success (1)
Deployment of main branch (MB) stent with \<20% residual stenosis and a patent side branch at end of procedure upon corelab analysis
Time frame: Intraoperative, up to 12 months
Technical success (2)
Total procedure time
Time frame: Intraoperative, up to 12 months
Technical success (3)
Acute gain in main and side branches as measured with a dedicated quantitative coronary analysis (QCA) software
Time frame: up to 12 months
Technical success (4)
Fluoroscopy time
Time frame: Intraoperative, up to 12 months
Technical success (5)
Total radiation dose (air kerma)
Time frame: Intraoperative, up to 12 months
Technical success (6)
Total contrast dose
Time frame: Intraoperative, up to 12 months
Technical success (6)
Need to cross over (any intervention on SB in the test arm or failure to intervene on the SB in the control arm)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU Timone Adultes
Marseille, France
Hôpital Privé Jacques Cartier ICPS
Massy, France
Clinique du Pont de chaume
Montauban, France
CHU Nîmes
Nîmes, France
Hôpital Privé Claude Galien ICPS
Quincy-sous-Sénart, France
Clinique Saint Hilaire
Rouen, France
CHU Toulouse Rangueuil
Toulouse, France
Universita' Cattolica del Sacro Cuore
Roma, Italy
...and 10 more locations
Time frame: Intraoperative, up to 12 months
Target Lesion Failure (TLF)
Composite of: * Cardiac Death * Target vessel Myocardial Infarction * Clinically driven Target lesion revascularization (ci-TLR)
Time frame: 1 month and 12 months
Target Lesion Revascularization (TLR)
Main Branch \& Side Branch TLR
Time frame: 1 month and 12 months
Stent thrombosis:
Definite or Probable stent thrombosis (ARC-2 criteria)
Time frame: 1 month and 12 months
Angina status
Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4)
Time frame: 1 month and 12 months