Status:
ACTIVE_NOT_RECRUITING
Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
Lead Sponsor:
ECRI bv
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Complex Coronary Lesions
Eligibility:
All Genders
18+ years
Phase:
NA
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 ultra...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2025
Estimated Enrollment :
2022 Patients enrolled
Trial Details
Trial ID
NCT04854070
Start Date
November 2 2021
End Date
September 7 2025
Last Update
September 25 2024
Active Locations (37)
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1
OLVZ
Aalst, Belgium
2
CHU
Charleroi, Belgium
3
ZOL Sint-Jan
Genk, Belgium
4
University Hospital Gasthuisberg
Leuven, Belgium