Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

Complex Coronary Lesions Clinical Trial

— IVUS-CHIP  

Official title:

Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04854070
• Other study ID #: ECRI-14
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: September 7, 2025

Study information

• Verified date: August 2023
• Source: ECRI bv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2022
• Est. completion date: September 7, 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complex Coronary Lesions

Intervention

Device:
• IVUS
IVUS-guided approach in patients with complex coronary lesions undergoing PCI
• Angio
Angio-guided approach in patients with complex coronary lesions undergoing PCI

Locations

Country	Name	City	State
Belgium	OLVZ	Aalst
Belgium	CHU	Charleroi
Belgium	ZOL Sint-Jan	Genk
Belgium	University Hospital Gasthuisberg	Leuven
France	Clinique Saint-Augustin	Bordeaux
France	Cardiovascular Institute of Grenoble, GHM	Grenoble
France	Hopital Privé Jacques Cartier	Massy
France	Centre Cardiologique du Nord Saint-Denis	Saint-Denis
France	CHU	Toulouse
France	Clinique Pasteur	Toulouse
France	CHRU Tours - HopitalTrousseau	Tours
Germany	Segeberger Kliniken	Bad Segeberg
Germany	Charite Universitatsmedizin Berlin	Berlin
Germany	Heart Center Dresden	Dresden
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	University of Giessen	Gießen
Germany	MediClin Heartcenter Lahr	Lahr
Italy	University of Ferrara	Ferrara
Italy	Humanitas Research Hospital	Milan
Italy	Ospedale degli infermi di Rivoli	Rivoli
Italy	Ospedale dell'Angelo	Venezia
Netherlands	Noordwest Hospital Group	Alkmaar
Netherlands	VuMC	Amsterdam
Netherlands	Albert Schweitzer hospital	Dordrecht
Netherlands	Catharina hospital	Eindhoven
Netherlands	Erasmus University Medical Center	Rotterdam
Spain	Bellvitge University Hospital	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Reina Sofia Hospital	Córdoba
Spain	Hospital la Paz	Madrid
Spain	La Princesa University Hospital	Madrid
Spain	Marques de Valdecilla University Hospital	Santander
Spain	University Clinical Hospital of Valladolid	Valladolid
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	St. George's University Hospital	London
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
ECRI bv	Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions	Target-vessel failure is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Secondary	Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization	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
Secondary	Clinically-indicated target vessel revascularization	Clinically-indiated target vessel revascularization is defined as any clinically-indicated repeat percutaneous intervention or surgical bypass of any segment of the target vessel	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Secondary	Composite of cardiac death and target-vessel myocardial infarction	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
Secondary	Target-Lesion Failure (TLF)	Target-Lesion Failure is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Secondary	Target-lesion revascularization	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	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Secondary	Cardiac death	Cardiac death is defined as death resulting from cardiovascular causes	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up