IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact
- Conditions
- Atherosclerosis
- Interventions
- Device: Eagle Eye Platinum digital IVUS catheter with optional SyncVisionDevice: Resolute Onyx Drug Eluting StentDevice: Onyx Frontier Drug Eluting StentDevice: Onyx TruStar Drug Eluting StentDevice: Onyx TruCor Drug Eluting Stent
- Registration Number
- NCT04221815
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3100
- 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
- Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock
- Use of fibrinolytic therapy within 24 hours of PCI
- Planned revascularization of a target vessel as a staged procedure
- Stent thrombosis
- Use of optical coherence tomography (OCT) during the index procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVUS guided PCI Onyx TruCor Drug Eluting Stent Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS IVUS guided PCI Resolute Onyx Drug Eluting Stent Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS IVUS guided PCI Onyx Frontier Drug Eluting Stent Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS Angiographic-guided PCI Onyx TruStar Drug Eluting Stent Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator IVUS guided PCI Eagle Eye Platinum digital IVUS catheter with optional SyncVision Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS Angiographic-guided PCI Onyx TruCor Drug Eluting Stent Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator IVUS guided PCI Onyx TruStar Drug Eluting Stent Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS Angiographic-guided PCI Resolute Onyx Drug Eluting Stent Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator Angiographic-guided PCI Onyx Frontier Drug Eluting Stent Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator
- Primary Outcome Measures
Name Time Method IVUS core lab measures final PCI Minimum Stent Area 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. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Good Samaritan University Hospital
🇺🇸West Islip, New York, United States
Thriassion General Hospital
🇬🇷Magoúla, Greece
University of California San Deigo
🇺🇸La Jolla, California, United States
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Rheinland Klinikum
🇩🇪Neuss, Germany
University Hospital Careggi
🇮🇹Florence, Italy
St. Vinzenz Hospital
🇩🇪Cologne, North Rhine Westphalia, Germany
Northwell Health - South Shore University Hospital
🇺🇸Bay Shore, New York, United States
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany
SUNY Upstate Medical Center
🇺🇸Syracuse, New York, United States
Helios Amper-Klinikum Dachau
🇩🇪Dachau, Germany
University of North Carolina Rex Hospital
🇺🇸Raleigh, North Carolina, United States
St. Francis
🇺🇸Roslyn, New York, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
AtlantiCare Regional Medical Center
🇺🇸Pomona, New Jersey, United States
NYU Langone Hospital
🇺🇸Brooklyn, New York, United States
Seton Medical Center Austin
🇺🇸Austin, Texas, United States
Northwell Health - North Shore University Hospital
🇺🇸Manhasset, New York, United States
DRK Kliniken Berlin Köpenik
🇩🇪Berlin, Germany
Meir Medical Center
🇮🇱Kfar Saba, Israel
Skane University Hospital
🇸🇪Lund, Sweden
Northwell Health - Lennox Hill Hospital
🇺🇸New York, New York, United States
Herz-und Diabeteszentrum NRW
🇩🇪Bad Oeynhausen, NRW, Germany
General Hospital of Athens Hippokration
🇬🇷Athens, Greece
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Segerberger Kliniken
🇩🇪Bad Segeberg, Germany
Shamir Medical Center
🇮🇱Be'er Ya'aqov, Israel
University of Messina
🇮🇹Messina, Italy
Danderyd University Hospital
🇸🇪Stockholm, Sweden
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Ascension Sacred Heart
🇺🇸Pensacola, Florida, United States
Rush University Medial Center
🇺🇸Chicago, Illinois, United States
Emory
🇺🇸Atlanta, Georgia, United States
AdventHealth Sebring
🇺🇸Sebring, Florida, United States
Northwest Medical Center
🇺🇸Tucson, Arizona, United States
Central Arkansas Veterans Healthcare System
🇺🇸Little Rock, Arkansas, United States
San Antonio Regional Hospital
🇺🇸Upland, California, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Atlanta VA Medical Center
🇺🇸Decatur, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Riverside Medical Center
🇺🇸Kankakee, Illinois, United States
MercyOne Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
MedStar Southern Maryland Hospital Center
🇺🇸Clinton, Maryland, United States
MedStar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Ascension St. John
🇺🇸Dearborn, Michigan, United States
St. Luke's Hospital of Duluth
🇺🇸Duluth, Minnesota, United States
Virtua Our Lady of Lourdes Hospital
🇺🇸Camden, New Jersey, United States
Freeman Hospital
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
San Francisco VA Health Care System
🇺🇸San Francisco, California, United States
Leeds General Infirmary
🇬🇧Leeds, West Yorkshire, United Kingdom
University Medicine Rostock
🇩🇪Rostock, Germany
Tampa Cardiovascular/St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Imperial College Healthcare
🇬🇧London, United Kingdom