Coronary DiseaseKISSNCT04285372
Keep bIfurcation Single Stenting Simple
A study testing Side branch protection/ballooning and No side branch protection/ballooning in people with Coronary Disease, run by Ceric Sàrl at 20 sites in 6 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Side branch protection/ballooning and No side branch protection/ballooning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 3 Aug 2020to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
France9 sites
CHU Caen
Caen, 14033
Hôpital Privé Dijon Bourgogne
Dijon, 21000
CHU Timone Adultes
Marseille, 13385
Hôpital Privé Jacques Cartier ICPS
Massy, 91300
Clinique du Pont de chaume
Montauban, 82000
CHU Nîmes
Nîmes, 30029
Hôpital Privé Claude Galien ICPS
Quincy-sous-Sénart, 91480
Clinique Saint Hilaire
Rouen, 76000
CHU Toulouse Rangueuil
Toulouse, 31959
Spain4 sites
Hospital Universitario Reina Sofia
Córdoba
Hospital de Cabuenes
Gijón
Hospital Clinico San Carlos
Madrid
Hospital Universitario 12 de Octubre
Madrid
Italy3 sites
Universita' Cattolica del Sacro Cuore
Roma
Istituto Clinico Humanitas
Rozzano
IRCCS Policlinico San Donato
San Donato
United Kingdom2 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
Freeman Hospital Newcastle
Newcastle, Tyne and Wear, NE7 7DN
About this study
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
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
Read the 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.
- Conditions
- Coronary Disease
- Being tested
- Side branch protection/ballooning, No side branch protection/ballooning
- Keywords
- Coronary disease, Bifurcation lesion
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side branch protection/ballooningProcedure or surgery
Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
No side branch protection/ballooningProcedure or surgery
No intervention on the side branch
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | No intervention on the side branch in the context of percutaneous coronary intervention for the treatment of bifurcation lesion Receives: Procedure: No side branch protection/ballooning |
| Control group | Active comparator | Side branch protection: Ballooning or Kissing Balloon Technique, in the context of percutaneous coronary intervention for the treatment of bifurcation lesion Receives: Procedure: Side branch protection/ballooning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 48 hours post-procedure, up to 12 months
Secondary outcomes (11)
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
Measured: Intraoperative, up to 12 months
Technical success (2)
Total procedure time
Measured: Intraoperative, up to 12 months
Technical success (3)
Acute gain in main and side branches as measured with a dedicated quantitative coronary analysis (QCA) software
Measured: up to 12 months
Technical success (4)
Fluoroscopy time
Measured: Intraoperative, up to 12 months
Technical success (5)
Total radiation dose (air kerma)
Measured: Intraoperative, up to 12 months
Technical success (6)
Total contrast dose
Measured: Intraoperative, up to 12 months
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)
Measured: Intraoperative, up to 12 months
Target Lesion Failure (TLF)
Composite of:
- Cardiac Death
- Target vessel Myocardial Infarction
- Clinically driven Target lesion revascularization (ci-TLR)
Measured: 1 month and 12 months
Target Lesion Revascularization (TLR)
Main Branch \& Side Branch TLR
Measured: 1 month and 12 months
Stent thrombosis:
Definite or Probable stent thrombosis (ARC-2 criteria)
Measured: 1 month and 12 months
Angina status
Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4)
Measured: 1 month and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start3 Aug 2020
- Primary completion11 Dec 2022
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard CHEVALIER, MD, Principal investigator, ICPS - Institut Cardiovasculaire Paris Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285372
- Sponsor's protocol ID
- KISS
- Acronym
- KISS
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04285372
- Acronym / sponsor ID
- KISS / KISS
- Conditions
- Coronary Disease
- Keywords
- Coronary disease, Bifurcation lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Ceric SàrlIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- Apr 2024 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: No side branch protection/ballooningNo intervention on the side branch in the context of percutaneous coronary intervention for the treatment of bifurcation lesion |
| Control group | Active comparator | Procedure: Side branch protection/ballooningSide branch protection: Ballooning or Kissing Balloon Technique, in the context of percutaneous coronary intervention for the treatment of bifurcation lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Side branch protection/ballooningSide branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion | Procedure or surgery | Control group |
| No side branch protection/ballooningNo intervention on the side branch | Procedure or surgery | Test group |
Primary outcome
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
11 secondary outcomes
Technical success (1)
Time frame: Intraoperative, up to 12 months
Technical success (2)
Time frame: Intraoperative, up to 12 months
Technical success (3)
Time frame: up to 12 months
Technical success (4)
Time frame: Intraoperative, up to 12 months
Technical success (5)
Time frame: Intraoperative, up to 12 months
Technical success (6)
Time frame: Intraoperative, up to 12 months
Technical success (6)
Time frame: Intraoperative, up to 12 months
Target Lesion Failure (TLF)
Time frame: 1 month and 12 months
Target Lesion Revascularization (TLR)
Time frame: 1 month and 12 months
Stent thrombosis:
Time frame: 1 month and 12 months
Angina status
Time frame: 1 month and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard CHEVALIER, MD principal investigator
ICPS - Institut Cardiovasculaire Paris Sud
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Side branch protection/ballooning and No side branch protection/ballooning in people with Coronary Disease, run by Ceric Sàrl at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Spain, Italy, United Kingdom, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprocedural Myocardial infarction (time frame: up to 48 hours post-procedure, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.