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Keep bIfurcation Single Stenting Simple (KISS)

Primary Purpose

Coronary Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Side branch protection/ballooning
No side branch protection/ballooning
Sponsored by
Ceric Sàrl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Coronary disease, Bifurcation lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Caen
  • Hôpital Privé Dijon Bourgogne
  • CHU Timone Adultes
  • Hôpital Privé Jacques Cartier ICPS
  • Clinique du Pont de chaume
  • CHU Nîmes
  • Hôpital Privé Claude Galien ICPS
  • Clinique Saint Hilaire
  • CHU Toulouse Rangueuil
  • Universita' Cattolica del Sacro Cuore
  • Istituto Clinico Humanitas
  • IRCCS Policlinico San Donato
  • Hospital de Santa Cruz
  • Hospital Universitario Reina Sofia
  • Hospital de Cabuenes
  • Hospital Clinico San Carlos
  • Hospital Universitario 12 de Octubre
  • CHUV Centre Hospitalier Universitaire Vaudois
  • Freeman Hospital Newcastle
  • Royal Sussex County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group

Control group

Arm Description

No intervention on the side branch in the context of percutaneous coronary intervention for the treatment of bifurcation lesion

Side branch protection: Ballooning or Kissing Balloon Technique, in the context of percutaneous coronary intervention for the treatment of bifurcation lesion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Technical success (1)
Deployment of main branch (MB) stent with <20% residual stenosis and a patent side branch at end of procedure upon corelab analysis
Technical success (2)
Total procedure time
Technical success (3)
Acute gain in main and side branches as measured with a dedicated quantitative coronary analysis (QCA) software
Technical success (4)
Fluoroscopy time
Technical success (5)
Total radiation dose (air kerma)
Technical success (6)
Total contrast dose
Technical success (6)
Need to cross over (any intervention on SB in the test arm or failure to intervene on the SB in the control arm)
Target Lesion Failure (TLF)
Composite of: Cardiac Death Target vessel Myocardial Infarction Clinically driven Target lesion revascularization (ci-TLR)
Target Lesion Revascularization (TLR)
Main Branch & Side Branch TLR
Stent thrombosis:
Definite or Probable stent thrombosis (ARC-2 criteria)
Angina status
Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4)

Full Information

First Posted
February 21, 2020
Last Updated
December 23, 2022
Sponsor
Ceric Sàrl
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1. Study Identification

Unique Protocol Identification Number
NCT04285372
Brief Title
Keep bIfurcation Single Stenting Simple
Acronym
KISS
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
December 11, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ceric Sàrl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Coronary disease, Bifurcation lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
No intervention on the side branch in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Side branch protection: Ballooning or Kissing Balloon Technique, in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
Intervention Type
Procedure
Intervention Name(s)
Side branch protection/ballooning
Intervention Description
Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
Intervention Type
Procedure
Intervention Name(s)
No side branch protection/ballooning
Intervention Description
No intervention on the side branch
Primary Outcome Measure Information:
Title
Periprocedural Myocardial infarction
Description
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
Time Frame
up to 48 hours post-procedure, up to 12 months
Secondary Outcome Measure Information:
Title
Technical success (1)
Description
Deployment of main branch (MB) stent with <20% residual stenosis and a patent side branch at end of procedure upon corelab analysis
Time Frame
Intraoperative, up to 12 months
Title
Technical success (2)
Description
Total procedure time
Time Frame
Intraoperative, up to 12 months
Title
Technical success (3)
Description
Acute gain in main and side branches as measured with a dedicated quantitative coronary analysis (QCA) software
Time Frame
up to 12 months
Title
Technical success (4)
Description
Fluoroscopy time
Time Frame
Intraoperative, up to 12 months
Title
Technical success (5)
Description
Total radiation dose (air kerma)
Time Frame
Intraoperative, up to 12 months
Title
Technical success (6)
Description
Total contrast dose
Time Frame
Intraoperative, up to 12 months
Title
Technical success (6)
Description
Need to cross over (any intervention on SB in the test arm or failure to intervene on the SB in the control arm)
Time Frame
Intraoperative, up to 12 months
Title
Target Lesion Failure (TLF)
Description
Composite of: Cardiac Death Target vessel Myocardial Infarction Clinically driven Target lesion revascularization (ci-TLR)
Time Frame
1 month and 12 months
Title
Target Lesion Revascularization (TLR)
Description
Main Branch & Side Branch TLR
Time Frame
1 month and 12 months
Title
Stent thrombosis:
Description
Definite or Probable stent thrombosis (ARC-2 criteria)
Time Frame
1 month and 12 months
Title
Angina status
Description
Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4)
Time Frame
1 month and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard CHEVALIER, MD
Organizational Affiliation
ICPS - Institut Cardiovasculaire Paris Sud
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Privé Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU Timone Adultes
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Privé Jacques Cartier ICPS
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Clinique du Pont de chaume
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
CHU Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital Privé Claude Galien ICPS
City
Quincy-sous-Sénart
ZIP/Postal Code
91480
Country
France
Facility Name
Clinique Saint Hilaire
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
CHU Toulouse Rangueuil
City
Toulouse
ZIP/Postal Code
31959
Country
France
Facility Name
Universita' Cattolica del Sacro Cuore
City
Roma
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Facility Name
IRCCS Policlinico San Donato
City
San Donato
Country
Italy
Facility Name
Hospital de Santa Cruz
City
Lisboa
Country
Portugal
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
Country
Spain
Facility Name
Hospital de Cabuenes
City
Gijón
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
CHUV Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland
Facility Name
Freeman Hospital Newcastle
City
Newcastle
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Keep bIfurcation Single Stenting Simple

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