Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
596 participants
INTERVENTIONAL
2020-08-03
2024-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Test group
No intervention on the side branch in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
No side branch protection/ballooning
No intervention on the side branch
Control group
Side branch protection: Ballooning or Kissing Balloon Technique, in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
Side branch protection/ballooning
Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
Interventions
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Side branch protection/ballooning
Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
No side branch protection/ballooning
No intervention on the side branch
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Ceric Sàrl
INDUSTRY
Responsible Party
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Principal Investigators
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Bernard CHEVALIER, MD
Role: PRINCIPAL_INVESTIGATOR
ICPS - Institut Cardiovasculaire Paris Sud
Locations
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CHU Caen
Caen, , France
Hôpital Privé Dijon Bourgogne
Dijon, , France
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
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, United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Countries
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Other Identifiers
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KISS
Identifier Type: -
Identifier Source: org_study_id
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