IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)
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|ClinicalTrials.gov Identifier: NCT04221815|
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||Device: Eagle Eye Platinum digital IVUS catheter with optional SyncVision Device: Resolute Onyx Drug Eluting Stent||Not Applicable|
This is a prospective, single-blind clinical investigation randomizing subjects to IVUS-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio.
The clinical investigation will be conducted at approximately 120 centers in the US, Canada, and Europe. Approximately 2,500-3,100 randomized subjects and up to 3 roll-in subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 2 years. The expected duration of enrollment is approximately 2.5 years. The total duration of the clinical investigation is expected to be approximately 4.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)|
|Actual Study Start Date :||October 14, 2020|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||August 2025|
Active Comparator: IVUS guided PCI
Patients will recieve a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS
Device: Eagle Eye Platinum digital IVUS catheter with optional SyncVision
Device: Resolute Onyx Drug Eluting Stent
Placebo Comparator: Angiographic-guided PCI
Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator
Device: Resolute Onyx Drug Eluting Stent
- IVUS core lab measures final PCI Minimum Stent Area [ Time Frame: Intra-procedural ]The imaging primary endpoint is the final post-PCI minimum stent area (MSA) assessed by IVUS in each randomized arm, measured at an independent IVUS core laboratory blinded to treatment assignment. The MSA is an appropriate co-primary imaging endpoint as it is the most consistent and strongest parameter to predict clinical outcomes.11-14 In the present study, after 2,000 subjects are enrolled with the procedure completed, the primary endpoint of MSA will be tested to compare the IVUS-guided and angiography-guided arms. If significantly larger MSA in the IVUS-guided arm is demonstrated, the trial will continue enrolling subjects.
- Target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related-myocardial infarction (MI), and ischemia-driven target vessel revascularization. [ Time Frame: 12 months ]The clinical primary endpoint is target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related- myocardial infarction (MI), and target vessel revascularization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221815
|Contact: Megan Rowland, MPHemail@example.com|
|United States, District of Columbia|
|Medstar Washington Hospital Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Megan Rowland, MPH firstname.lastname@example.org|
|Principal Investigator: Itsik Ben-Dor, MD|