- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04285372
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Caen, France, 14033
- CHU caen
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Dijon, France, 21000
- Hôpital Privé Dijon Bourgogne
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Marseille, France, 13385
- CHU Timone Adultes
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Massy, France, 91300
- Hôpital Privé Jacques Cartier ICPS
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Montauban, France, 82000
- Clinique Du Pont De Chaume
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Nîmes, France, 30029
- Chu Nimes
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Quincy-sous-Sénart, France, 91480
- Hôpital Privé Claude Galien ICPS
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Rouen, France, 76000
- Clinique Saint Hilaire
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Toulouse, France, 31959
- CHU Toulouse Rangueuil
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Roma, Italy
- Universita' Cattolica del Sacro Cuore
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Rozzano, Italy
- Istituto Clinico Humanitas
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San Donato, Italy
- IRCCS Policlinico San Donato
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Lisboa, Portugal
- Hospital de Santa Cruz
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Córdoba, Spain
- Hospital Universitario Reina Sofia
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Gijón, Spain
- Hospital de Cabueñes
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Madrid, Spain
- Hospital Universitario 12 de octubre
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Madrid, Spain
- Hospital Clinico San Carlos
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Lausanne, Switzerland
- CHUV centre hospitalier universitaire vaudois
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Brighton, United Kingdom, BN2 5BE
- Royal Sussex County Hospital
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Tyne And Wear
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Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
- Freeman Hospital Newcastle
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test group
No intervention on the side branch in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
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No intervention on the side branch
|
Active Comparator: Control group
Side branch protection: Ballooning or Kissing Balloon Technique, in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
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Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periprocedural Myocardial infarction
Time Frame: up to 48 hours post-procedure, up to 12 months
|
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
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up to 48 hours post-procedure, up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical success (1)
Time Frame: Intraoperative, up to 12 months
|
Deployment of main branch (MB) stent with <20% residual stenosis and a patent side branch at end of procedure upon corelab analysis
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Intraoperative, up to 12 months
|
Technical success (2)
Time Frame: Intraoperative, up to 12 months
|
Total procedure time
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Intraoperative, up to 12 months
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Technical success (3)
Time Frame: up to 12 months
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Acute gain in main and side branches as measured with a dedicated quantitative coronary analysis (QCA) software
|
up to 12 months
|
Technical success (4)
Time Frame: Intraoperative, up to 12 months
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Fluoroscopy time
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Intraoperative, up to 12 months
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Technical success (5)
Time Frame: Intraoperative, up to 12 months
|
Total radiation dose (air kerma)
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Intraoperative, up to 12 months
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Technical success (6)
Time Frame: Intraoperative, up to 12 months
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Total contrast dose
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Intraoperative, up to 12 months
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Technical success (6)
Time Frame: Intraoperative, up to 12 months
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Need to cross over (any intervention on SB in the test arm or failure to intervene on the SB in the control arm)
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Intraoperative, up to 12 months
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Target Lesion Failure (TLF)
Time Frame: 1 month and 12 months
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Composite of:
|
1 month and 12 months
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Target Lesion Revascularization (TLR)
Time Frame: 1 month and 12 months
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Main Branch & Side Branch TLR
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1 month and 12 months
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Stent thrombosis:
Time Frame: 1 month and 12 months
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Definite or Probable stent thrombosis (ARC-2 criteria)
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1 month and 12 months
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Angina status
Time Frame: 1 month and 12 months
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Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4)
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1 month and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bernard CHEVALIER, MD, ICPS - Institut Cardiovasculaire Paris Sud
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KISS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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