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.
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 at least 169 patients have experienced an event.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,020
OLVZ
Aalst, Belgium
CHU
Charleroi, Belgium
ZOL Sint-Jan
Genk, Belgium
University Hospital Gasthuisberg
Leuven, Belgium
Clinique Saint-Augustin
Bordeaux, France
Cardiovascular Institute of Grenoble, GHM
Grenoble, France
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
Time frame: 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
Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
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
Time frame: 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 cardiac death and target-vessel myocardial infarction
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
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
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
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
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Cardiac death
Cardiac death is defined as death resulting from cardiovascular causes
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
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Hopital Privé Jacques Cartier
Massy, France
Centre Cardiologique du Nord Saint-Denis
Saint-Denis, France
CHU
Toulouse, France
Clinique Pasteur
Toulouse, France
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