Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
- Conditions
- Complex Coronary Lesions
- Interventions
- Device: IVUSDevice: Angio
- Registration Number
- NCT04854070
- Lead Sponsor
- ECRI bv
- Brief Summary
The IVUS CHIP trial is a post-marketing strategy study in which patients with complex coronary lesions, undergoing percutaneous coronary intervention (PCI), are treated either with intravascular ultrasound (IVUS) guided PCI or angiographic guided PCI .
The IVUS-guided PCI approach is indicated to reduce the frequency of target-lesion failure (cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization) in patients with complex coronary lesions undergoing PCI.
The objective of this study is to assess the superiority of an IVUS-guided approach versus an angio-guided approach in patients with complex coronary lesions undergoing PCI.
- Detailed Description
During percutaneous coronary intervention (PCI) coronary arteries are visualized to guide placing the stent. In this study 2 currently utilized methods of visualizing coronary arteries during PCI are compared: intravascular ultrasound (IVUS) and angiographic guided PCI for patients with complex coronary lesions.The use of IVUS during PCI is suggested to give better results than angiographic guided PCI.
The IVUS-CHIP trial is a randomized, controlled, multicenter, international, post-marketing study. A total of 2020 patients, in 7 European countries and approximately 40 hospitals, will be included, randomized in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI, and followed up for at least 2 years.
The IVUS-CHIP is an event-driven study; primary analysis of the data will take place after 169 patients have experienced an event.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2022
All of the following:
-
The patient must be ≥18 years of age
-
Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
- Angiographic heavy calcification
- Ostial lesions
- True bifurcation lesions involving side-branches >2.5mm
- Left main lesions
- Chronic total occlusion
- In-stent restenosis
- Long-lesions (estimated stent length > 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
-
Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
-
All lesions must be suitable for treatment with the Synergy stent system, Synergy Megatron system, or other Synergy platform iteration
-
The patient is willing and able to cooperate with study procedures and follow-up until study completion
-
Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee
Any of the following:
- ST-elevation myocardial infarction, cardiogenic shock
- Known untreated severe valvular heart disease
- IVUS is strictly required for pre-PCI lesion severity assessment
- Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
- Non-cardiac co-morbidities with a life expectancy less than 1 year
- Currently participating in another trial that is not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
- Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding
- Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVUS-guided PCI IVUS Method is already used in standard care, but in this trial compared to another method also already used in standard care Angio-guided PCI Angio Method is standard care
- Primary Outcome Measures
Name Time Method Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up Target-vessel failure is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
- Secondary Outcome Measures
Name Time Method Composite of cardiac death and target-vessel myocardial infarction From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up Composite of cardiac death and target-vessel myocardial infarction
Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization
Clinically-indicated target vessel revascularization From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up Clinically-indiated target vessel revascularization is defined as any clinically-indicated repeat percutaneous intervention or surgical bypass of any segment of the target vessel
Cardiac death From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up Cardiac death is defined as death resulting from cardiovascular causes
Target-Lesion Failure (TLF) From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up Target-Lesion Failure is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization
Target-lesion revascularization From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up Target-lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion
Trial Locations
- Locations (36)
Noordwest Hospital Group
🇳🇱Alkmaar, Netherlands
Ospedale degli infermi di Rivoli
🇮🇹Rivoli, Italy
Catharina hospital
🇳🇱Eindhoven, Netherlands
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Humanitas Research Hospital
🇮🇹Milan, Italy
Ospedale dell'Angelo
🇮🇹Venezia, Italy
Heart Center Dresden
🇩🇪Dresden, Germany
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
OLVZ
🇧🇪Aalst, Belgium
CHU
🇫🇷Toulouse, France
University of Ferrara
🇮🇹Ferrara, Italy
Bellvitge University Hospital
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Reina Sofia Hospital
🇪🇸Córdoba, Spain
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
St. George's University Hospital
🇬🇧London, United Kingdom
Hopital Privé Jacques Cartier
🇫🇷Massy, France
Centre Cardiologique du Nord Saint-Denis
🇫🇷Saint-Denis, France
CHRU Tours - HopitalTrousseau
🇫🇷Tours, France
Clinique Saint-Augustin
🇫🇷Bordeaux, France
Cardiovascular Institute of Grenoble, GHM
🇫🇷Grenoble, France
Segeberger Kliniken
🇩🇪Bad Segeberg, Germany
Clinique Pasteur
🇫🇷Toulouse, France
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
MediClin Heartcenter Lahr
🇩🇪Lahr, Germany
University of Giessen
🇩🇪Gießen, Germany
Albert Schweitzer hospital
🇳🇱Dordrecht, Netherlands
VuMC
🇳🇱Amsterdam, Netherlands
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Hospital la Paz
🇪🇸Madrid, Spain
La Princesa University Hospital
🇪🇸Madrid, Spain
University Clinical Hospital of Valladolid
🇪🇸Valladolid, Spain
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Marques de Valdecilla University Hospital
🇪🇸Santander, Spain
University Hospital Gasthuisberg
🇧🇪Leuven, Belgium
ZOL Sint-Jan
🇧🇪Genk, Belgium