Clinical trial NCT04285372: Keep bIfurcation Single Stenting Simple
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Disease
Keywords: Coronary disease
Bifurcation lesion
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
First posted: 2020-02-26
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Periprocedural Myocardial infarction
timeFrame: up to 48 hours post-procedure, up to 12 months
Secondary outcomes:
measure: Technical success (1)
timeFrame: Intraoperative, up to 12 months
measure: Technical success (2)
timeFrame: Intraoperative, up to 12 months
measure: Technical success (3)
timeFrame: up to 12 months
measure: Technical success (4)
timeFrame: Intraoperative, up to 12 months
measure: Technical success (5)
timeFrame: Intraoperative, up to 12 months
measure: Technical success (6)
timeFrame: Intraoperative, up to 12 months
measure: Technical success (6)
timeFrame: Intraoperative, up to 12 months
measure: Target Lesion Failure (TLF)
timeFrame: 1 month and 12 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 1 month and 12 months
measure: Stent thrombosis:
timeFrame: 1 month and 12 months
measure: Angina status
timeFrame: 1 month and 12 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
city: Dijon
country: France
facility: Hôpital Privé Dijon Bourgogne
city: Marseille
country: France
facility: CHU Timone Adultes
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier ICPS
city: Montauban
country: France
facility: Clinique du Pont de chaume
city: Nîmes
country: France
facility: CHU Nîmes
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien ICPS
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Toulouse
country: France
facility: CHU Toulouse Rangueuil
city: Roma
country: Italy
facility: Universita' Cattolica del Sacro Cuore
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: San Donato
country: Italy
facility: IRCCS Policlinico San Donato
city: Lisboa
country: Portugal
facility: Hospital de Santa Cruz
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Gijón
country: Spain
facility: Hospital de Cabuenes
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Lausanne
country: Switzerland
facility: CHUV Centre Hospitalier Universitaire Vaudois
city: Newcastle
country: United Kingdom
facility: Freeman Hospital Newcastle
state: Tyne And Wear
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
Study officials:
affiliation: ICPS - Institut Cardiovasculaire Paris Sud
name: Bernard CHEVALIER, MD
role: PRINCIPAL_INVESTIGATOR
References: