Keep bIfurcation Single Stenting Simple
KISS
A Randomized, Prospective, Post-market, Multicenter Study to Evaluate the Potential Benefit of Side Branch Ballooning, in the Setting of Single Stenting With Systematic Proximal Optimization Technique, in the Treatment of Bifurcation Lesion
1 other identifier
interventional
596
6 countries
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedStudy Start
First participant enrolled
August 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJanuary 12, 2024
January 1, 2024
2.4 years
February 21, 2020
January 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
up to 48 hours post-procedure, up to 12 months
Secondary Outcomes (11)
Technical success (1)
Intraoperative, up to 12 months
Technical success (2)
Intraoperative, up to 12 months
Technical success (3)
up to 12 months
Technical success (4)
Intraoperative, up to 12 months
Technical success (5)
Intraoperative, up to 12 months
- +6 more secondary outcomes
Study Arms (2)
Test group
EXPERIMENTALNo intervention on the side branch in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
Control group
ACTIVE COMPARATORSide branch protection: Ballooning or Kissing Balloon Technique, in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
Interventions
Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
Eligibility Criteria
You may qualify if:
- Coronary artery disease requiring revascularization that is amenable to percutaneous coronary intervention (PCI)
- 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
- Side branch diameter compatible with a PCI with stent implantation (≥ 2.25mm)
- Side branch requiring a protection wire according to operator evaluation
- Anatomy compatible with a proximal optimization technique
- 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)
- Male or female patient \>18 years old
You may not qualify if:
- Acute myocardial infarction with ongoing ST-elevation
- Cardiogenic shock
- Requirement for ongoing hemodialysis
- Life-expectancy limited to \<12 months due to co-morbid condition
- Lesion involves the left main coronary artery
- Lesion requiring a double stenting
- Plan to treat \>1 other coronary vessel at the time of the index procedure
- 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.
- Chronic total occlusion of any target vessel
- Left ventricular ejection fraction \<20%
- Side branch TIMI Flow \<3
- Pre-dilatation of the Side Branch during the procedure prior to randomization
- Known allergy to Aspirin
- Known allergy to Clopidorel and Prasugrel and Ticagrelor
- Known allergy to stent drug elutant
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ceric Sàrllead
Study Sites (20)
CHU Caen
Caen, 14033, France
Hôpital Privé Dijon Bourgogne
Dijon, 21000, France
CHU Timone Adultes
Marseille, 13385, France
Hôpital Privé Jacques Cartier ICPS
Massy, 91300, France
Clinique du Pont de chaume
Montauban, 82000, France
CHU Nîmes
Nîmes, 30029, France
Hôpital Privé Claude Galien ICPS
Quincy-sous-Sénart, 91480, France
Clinique Saint Hilaire
Rouen, 76000, France
CHU Toulouse Rangueuil
Toulouse, 31959, France
Universita' Cattolica del Sacro Cuore
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
IRCCS Policlinico San Donato
San Donato, Italy
Hospital de Santa Cruz
Lisbon, Portugal
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital de Cabuenes
Gijón, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Freeman Hospital Newcastle
Newcastle, Tyne and Wear, NE7 7DN, United Kingdom
Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard CHEVALIER, MD
ICPS - Institut Cardiovasculaire Paris Sud
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2020
First Posted
February 26, 2020
Study Start
August 3, 2020
Primary Completion
December 11, 2022
Study Completion
April 1, 2024
Last Updated
January 12, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share