To assess the superiority of an IVUS-guided approach versus a qualitative angio-guided approach in patients with complex coronary lesions undergoing PCI.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
Target-vessel failure defined as a composite of cardiac death, target vessel
myocardial infarction*, or clinically indicated target-vessel revascularization
*ARC-2 1; 4th universal definition for spontaneous (>48 hours) MI 2.
Secondary outcome
Secondary endpoints:
1. Composite of target-vessel myocardial infarction and clinically indicated
target vessel revascularization
2. Clinically-indicated target vessel revascularization
3. Composite of cardiac death and target-vessel myocardial infarction
4. Target-Lesion Failure (TLF) defined as a composite of cardiac death, target
vessel myocardial infarction, or clinically indicated target-lesion
revascularization
5. Target-lesion revascularization
6. Cardiac death
Background summary
The use of intravascular ultrasound (IVUS) during PCI is suggested to give
better results than angiographic guided PCI. Clinical trials to confirm a
clinical benefit of IVUS and further define for which patients this method
would be most beneficial have not yet been performed. The purpose of this trial
is to collect this information for patients with complex coronary lesions
Study objective
To assess the superiority of an IVUS-guided approach versus a qualitative
angio-guided approach in patients with complex coronary lesions undergoing PCI.
Study design
The IVUS CHIP trial is a randomized, controlled, multicenter, international,
event-driven, post-marketing study. A total of 2020 participants will be
randomized in a 1:1 fashion to IVUS-guided PCI versus qualitative angio-guided
PCI, stratified by site. Patients will be consented prior to the PCI procedure
and then followed up to 2 years after the index procedure.
Intervention
IVUS-guided approach in patients with complex coronary lesions undergoing PCI.
Study burden and risks
No risk outside of standard of care, possible benefits as listed in E1b.
Westblaak 98
Rotterdam 3012 KM
NL
Westblaak 98
Rotterdam 3012 KM
NL
Listed location countries
Age
Inclusion criteria
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:
a. Angiographic heavy calcification
b. Ostial lesions
c. True bifurcation lesions involving side-branches >2.5mm
d. Left main lesions
e. Chronic total occlusion
f. In-stent restenosis
g. 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 recent
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
1. ST-elevation myocardial infarction, cardiogenic shock
2. Known untreated severe valvular heart disease
3. Known contraindication or hypersensitivity to everolimus, platinum-chromium,
or to anticoagulants
4. Absolute contraindications or allergy that cannot be pre-medicated, to
iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12
inhibitors
5. Non-cardiac co-morbidities with a life expectancy less than 1 year
6. 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 for at least 12 months after enrollment and may only be
enrolled once in the study
7. Women of childbearing potential who do not have a negative pregnancy test
within 7 days before the procedure and women who are breastfeeding
8. Subject belongs to a vulnerable population (per investigator*s judgment) or
subject unable to read or write
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04854070 |
| CCMO | NL76019.078.21 |