Keep bIfurcation Single Stenting Simple

Coronary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04285372
• Other study ID #: KISS
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Ceric Sàrl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 596
• Est. completion date: April 2024
• Est. primary completion date: December 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	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
Italy	Universita' Cattolica del Sacro Cuore	Roma
Italy	Istituto Clinico Humanitas	Rozzano
Italy	IRCCS Policlinico San Donato	San Donato
Portugal	Hospital de Santa Cruz	Lisboa
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital de Cabuenes	Gijón
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	CHUV Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Freeman Hospital Newcastle	Newcastle	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Ceric Sàrl

Countries where clinical trial is conducted

France,  Italy,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 48 hours post-procedure, up to 12 months
Secondary	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	Intraoperative, up to 12 months
Secondary	Technical success (2)	Total procedure time	Intraoperative, up to 12 months
Secondary	Technical success (3)	Acute gain in main and side branches as measured with a dedicated quantitative coronary analysis (QCA) software	up to 12 months
Secondary	Technical success (4)	Fluoroscopy time	Intraoperative, up to 12 months
Secondary	Technical success (5)	Total radiation dose (air kerma)	Intraoperative, up to 12 months
Secondary	Technical success (6)	Total contrast dose	Intraoperative, up to 12 months
Secondary	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)	Intraoperative, up to 12 months
Secondary	Target Lesion Failure (TLF)	Composite of: Cardiac Death; Target vessel Myocardial Infarction; Clinically driven Target lesion revascularization (ci-TLR)	1 month and 12 months
Secondary	Target Lesion Revascularization (TLR)	Main Branch & Side Branch TLR	1 month and 12 months
Secondary	Stent thrombosis:	Definite or Probable stent thrombosis (ARC-2 criteria)	1 month and 12 months
Secondary	Angina status	Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4)	1 month and 12 months