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KISS: Keep bIfurcation Single Stenting Simple

Sponsor
Ceric Sàrl (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04285372
Collaborator
(none)
596
Enrollment
20
Locations
2
Arms
26
Anticipated Duration (Months)
29.8
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Side branch protection/ballooning
  • Procedure: No side branch protection/ballooning
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
596 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Periprocedural Myocardial infarction [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

Secondary Outcome Measures

  1. Technical success (1) [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

  2. Technical success (2) [Intraoperative, up to 12 months]

    Total procedure time

  3. Technical success (3) [up to 12 months]

    Acute gain in main and side branches as measured with a dedicated quantitative coronary analysis (QCA) software

  4. Technical success (4) [Intraoperative, up to 12 months]

    Fluoroscopy time

  5. Technical success (5) [Intraoperative, up to 12 months]

    Total radiation dose (air kerma)

  6. Technical success (6) [Intraoperative, up to 12 months]

    Total contrast dose

  7. Technical success (6) [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)

  8. Target Lesion Failure (TLF) [1 month and 12 months]

    Composite of: Cardiac Death Target vessel Myocardial Infarction Clinically driven Target lesion revascularization (ci-TLR)

  9. Target Lesion Revascularization (TLR) [1 month and 12 months]

    Main Branch & Side Branch TLR

  10. Stent thrombosis: [1 month and 12 months]

    Definite or Probable stent thrombosis (ARC-2 criteria)

  11. Angina status [1 month and 12 months]

    Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Clinique du Pont de chaume Montauban France 82000
6 CHU Nîmes Nîmes France 30029
7 Hôpital Privé Claude Galien ICPS Quincy-sous-Sénart France 91480
8 Clinique Saint Hilaire Rouen France 76000
9 CHU Toulouse Rangueuil Toulouse France 31959
10 Universita' Cattolica del Sacro Cuore Roma Italy
11 Istituto Clinico Humanitas Rozzano Italy
12 IRCCS Policlinico San Donato San Donato Italy
13 Hospital de Santa Cruz Lisboa Portugal
14 Hospital Universitario Reina Sofia Córdoba Spain
15 Hospital de Cabuenes Gijón Spain
16 Hospital Clinico San Carlos Madrid Spain
17 Hospital Universitario 12 de Octubre Madrid Spain
18 CHUV Centre Hospitalier Universitaire Vaudois Lausanne Switzerland
19 Freeman Hospital Newcastle Newcastle Upon Tyne, Tyne and Wear Newcastle United Kingdom
20 John Radcliffe Hospital Oxford United Kingdom

Sponsors and Collaborators

  • Ceric Sàrl

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ceric Sàrl
ClinicalTrials.gov Identifier:
NCT04285372
Other Study ID Numbers:
  • KISS
First Posted:
Feb 26, 2020
Last Update Posted:
Jul 7, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ceric Sàrl
Coronary disease
Bifurcation lesion
Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease

Study Results

No Results Posted as of Jul 7, 2020