Status:
ACTIVE_NOT_RECRUITING
Keep bIfurcation Single Stenting Simple
Lead Sponsor:
Ceric Sàrl
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 protecti...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Known allergy to any other component of Onyx Resolute stent
- Ongoing participation in another investigational device or drug study
- Inability to provide informed consent
- Patients under judicial protection, tutorship or curatorship
- Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT04285372
Start Date
August 3 2020
End Date
April 1 2024
Last Update
January 12 2024
Active Locations (20)
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1
CHU Caen
Caen, France, 14033
2
Hôpital Privé Dijon Bourgogne
Dijon, France, 21000
3
CHU Timone Adultes
Marseille, France, 13385
4
Hôpital Privé Jacques Cartier ICPS
Massy, France, 91300