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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | No intervention on the side branch in the context of percutaneous coronary intervention for the treatment of bifurcation lesion |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Side branch protection/ballooning | Procedure | Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Technical success (2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard CHEVALIER, MD | ICPS - Institut Cardiovasculaire Paris Sud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen | Caen | 14033 | France | |||
| Hôpital Privé Dijon Bourgogne |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| No side branch protection/ballooning | Procedure | No intervention on the side branch |
|
Total procedure time
| 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 | up to 12 months |
| Technical success (4) | Fluoroscopy time | Intraoperative, up to 12 months |
| Technical success (5) | Total radiation dose (air kerma) | Intraoperative, up to 12 months |
| Technical success (6) | Total contrast dose | 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) | Intraoperative, up to 12 months |
| Target Lesion Failure (TLF) | Composite of:
| 1 month and 12 months |
| Target Lesion Revascularization (TLR) | Main Branch & Side Branch TLR | 1 month and 12 months |
| Stent thrombosis: | Definite or Probable stent thrombosis (ARC-2 criteria) | 1 month and 12 months |
| Angina status | Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4) | 1 month and 12 months |
| Dijon |
| 21000 |
| France |
| CHU Timone Adultes | Marseille | 13385 | France |
| Hôpital Privé Jacques Cartier ICPS | Massy | 91300 | France |
| Clinique du Pont de chaume | Montauban | 82000 | France |
| CHU Nîmes | Nîmes | 30029 | France |
| Hôpital Privé Claude Galien ICPS | Quincy-sous-Sénart | 91480 | France |
| Clinique Saint Hilaire | Rouen | 76000 | France |
| CHU Toulouse Rangueuil | Toulouse | 31959 | France |
| Universita' Cattolica del Sacro Cuore | Roma | Italy |
| Istituto Clinico Humanitas | Rozzano | Italy |
| IRCCS Policlinico San Donato | San Donato | Italy |
| Hospital de Santa Cruz | Lisbon | Portugal |
| Hospital Universitario Reina Sofia | Córdoba | Spain |
| Hospital de Cabuenes | Gijón | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| CHUV Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
| Freeman Hospital Newcastle | Newcastle | Tyne and Wear | NE7 7DN | United Kingdom |
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |