Clinical trial NCT04854070: Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
Official title: Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Complex Coronary Lesions
Keywords: Percutaneous coronary intervention
Angiographic guided PCI
Intra-vascular ultrasound guided PCI
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Boston Scientific Corporation
First posted: 2021-04-22
Enrollment: 2022
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

All of the following:

1. The patient must be ≥18 years of age
2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:

   1. Angiographic heavy calcification
   2. Ostial lesions
   3. True bifurcation lesions involving side-branches \>2.5mm
   4. Left main lesions
   5. Chronic total occlusion
   6. In-stent restenosis
   7. 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
3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
4. All lesions must be suitable for treatment with the Synergy stent system, Synergy Megatron system, or other Synergy platform iteration
5. The patient is willing and able to cooperate with study procedures and follow-up until study completion
6. 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

Exclusion Criteria:

Any of the following:

1. ST-elevation myocardial infarction, cardiogenic shock
2. Known untreated severe valvular heart disease
3. IVUS is strictly required for pre-PCI lesion severity assessment
4. Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants
5. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
6. Non-cardiac co-morbidities with a life expectancy less than 1 year
7. 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
8. Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding
9. Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write

Primary outcomes:
measure: Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions
timeFrame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Secondary outcomes:
measure: Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization
timeFrame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
measure: Clinically-indicated target vessel revascularization
timeFrame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
measure: Composite of cardiac death and target-vessel myocardial infarction
timeFrame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
measure: Target-Lesion Failure (TLF)
timeFrame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
measure: Target-lesion revascularization
timeFrame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
measure: Cardiac death
timeFrame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLVZ
city: Charleroi
country: Belgium
facility: CHU
city: Genk
country: Belgium
facility: ZOL Sint-Jan
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Bordeaux
country: France
facility: Clinique Saint-Augustin
city: Grenoble
country: France
facility: Cardiovascular Institute of Grenoble, GHM
city: Massy
country: France
facility: Hopital Privé Jacques Cartier
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord Saint-Denis
city: Toulouse
country: France
facility: CHU
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHRU Tours - HopitalTrousseau
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Dresden
country: Germany
facility: Heart Center Dresden
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Gießen
country: Germany
facility: University of Giessen
city: Lahr
country: Germany
facility: MediClin Heartcenter Lahr
city: Ferrara
country: Italy
facility: University of Ferrara
city: Milan
country: Italy
facility: Humanitas Research Hospital
city: Rivoli
country: Italy
facility: Ospedale degli infermi di Rivoli
city: Venezia
country: Italy
facility: Ospedale dell'Angelo
city: Alkmaar
country: Netherlands
facility: Noordwest Hospital Group
city: Amsterdam
country: Netherlands
facility: VuMC
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer hospital
city: Eindhoven
country: Netherlands
facility: Catharina hospital
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: Reina Sofia Hospital
city: Madrid
country: Spain
facility: Hospital la Paz
city: Madrid
country: Spain
facility: La Princesa University Hospital
city: Santander
country: Spain
facility: Marques de Valdecilla University Hospital
city: Valladolid
country: Spain
facility: University Clinical Hospital of Valladolid
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: St. George's University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Erasmus Medical Center
name: R. Diletti, Dr.
role: PRINCIPAL_INVESTIGATOR
References: