Keep bIfurcation Single Stenting Simple (KISS)

January 11, 2024 updated by: Ceric Sàrl

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

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

Study Overview

Status

Active, not recruiting

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

Interventional

Enrollment (Actual)

596

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • CHU Caen
      • Dijon, France, 21000
        • Hôpital privé Dijon Bourgogne
      • Marseille, France, 13385
        • CHU Timone Adultes
      • Massy, France, 91300
        • Hôpital Privé Jacques Cartier ICPS
      • Montauban, France, 82000
        • Clinique du Pont de Chaume
      • Nîmes, France, 30029
        • CHU Nîmes
      • Quincy-sous-Sénart, France, 91480
        • Hôpital Privé Claude Galien ICPS
      • Rouen, France, 76000
        • Clinique Saint Hilaire
      • Toulouse, France, 31959
        • CHU Toulouse Rangueuil
  • Italy
      • Roma, Italy
        • Universita' Cattolica del Sacro Cuore
      • Rozzano, Italy
        • Istituto Clinico Humanitas
      • San Donato, Italy
        • IRCCS Policlinico San Donato
  • Portugal
      • Lisboa, Portugal
        • Hospital de Santa Cruz
  • Spain
      • Córdoba, Spain
        • Hospital Universitario Reina Sofia
      • Gijón, Spain
        • Hospital de Cabueñes
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Clinico San Carlos
  • Switzerland
      • Lausanne, Switzerland
        • CHUV Centre Hospitalier Universitaire Vaudois
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
    • Tyne And Wear
      • Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
        • Freeman Hospital Newcastle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: No side branch protection/ballooning
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
Procedure: Side branch protection/ballooning
Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion

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
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
Intraoperative, up to 12 months
Technical success (2)
Time Frame: Intraoperative, up to 12 months
Total procedure time
Intraoperative, up to 12 months
Technical success (3)
Time Frame: up to 12 months
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
Fluoroscopy time
Intraoperative, up to 12 months
Technical success (5)
Time Frame: Intraoperative, up to 12 months
Total radiation dose (air kerma)
Intraoperative, up to 12 months
Technical success (6)
Time Frame: Intraoperative, up to 12 months
Total contrast dose
Intraoperative, up to 12 months
Technical success (6)
Time Frame: Intraoperative, up to 12 months
Need to cross over (any intervention on SB in the test arm or failure to intervene on the SB in the control arm)
Intraoperative, up to 12 months
Target Lesion Failure (TLF)
Time Frame: 1 month and 12 months

Composite of:

  • Cardiac Death
  • Target vessel Myocardial Infarction
  • Clinically driven Target lesion revascularization (ci-TLR)
1 month and 12 months
Target Lesion Revascularization (TLR)
Time Frame: 1 month and 12 months
Main Branch & Side Branch TLR
1 month and 12 months
Stent thrombosis:
Time Frame: 1 month and 12 months
Definite or Probable stent thrombosis (ARC-2 criteria)
1 month and 12 months
Angina status
Time Frame: 1 month and 12 months
Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4)
1 month and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceric Sàrl

Investigators

  • Principal Investigator: Bernard CHEVALIER, MD, ICPS - Institut Cardiovasculaire Paris Sud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Actual)

December 11, 2022

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Coronary Disease

Clinical Trials on No side branch protection/ballooning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe