Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04221815
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

Brief Summary:
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent events after PCI. This is accomplished by improving the angiographic result with lesion and vessel assessment to guide stent selection and implantation and intravascular imaging following stent implantation to ensure an adequate treatment endpoint has been achieved. Despite extensive literature supporting the use of IVUS in PCI, utilization remains low in the United States. An increasing number of high-risk or complex lesions are being treated with PCI and we hypothesize that the impact of IVUS in these complex lesions will be of increased importance in reducing clinical adverse events while remaining cost effective.

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

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
IVUS catheter

Device: Resolute Onyx Drug Eluting Stent
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
Stent




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years at screening
  • PCI with stent implantation involving a high risk or complex lesion defined as involving at least one of the following characteristics:
  • Chronic total occlusion
  • In-stent restenosis
  • Severe coronary artery calcification
  • Long lesion (≥ 28 mm in length)
  • Bifurcation lesion (Any Medina class that involves main branch disease with a side branch ≥2.0 mm)
  • Stable angina, unstable angina, or non-ST Elevation myocardial infarction (NSTEMI), undergoing PCI of a single or multivessel coronary artery stenosis
  • PCI performed with either angiography alone, or IVUS guidance used

Exclusion Criteria:

  • Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock
  • Use of fibrinolytic therapy within 24 hours of PCI
  • Planned revascularization as a staged procedure
  • Stent thrombosis
  • Use of optical coherence tomography (OCT) during the index procedure

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Megan Rowland, MPH 2028772959 megan.e.rowland@medstar.net

Locations
Layout table for location information
United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Megan Rowland, MPH       megan.e.rowland@medstar.net   
Principal Investigator: Itsik Ben-Dor, MD         
Sponsors and Collaborators
Medstar Health Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT04221815    
Other Study ID Numbers: IMPROVE
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases