Clinical trial NCT04221815: IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact
Official title: IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 3100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 of a target vessel as a staged procedure
* Stent thrombosis
* Use of optical coherence tomography (OCT) during the index procedure

Primary outcomes:
measure: IVUS core lab measures final PCI Minimum Stent Area
timeFrame: Intra-procedural
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Northwest Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Deigo
state: California
city: San Francisco
country: United States
facility: San Francisco VA Health Care System
state: California
city: Upland
country: United States
facility: San Antonio Regional Hospital
state: California
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Sebring
country: United States
facility: AdventHealth Sebring
state: Florida
city: Tampa
country: United States
facility: Tampa Cardiovascular/St. Joseph's Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Chicago
country: United States
facility: Rush University Medial Center
state: Illinois
city: Kankakee
country: United States
facility: Riverside Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Des Moines
country: United States
facility: MercyOne Iowa Heart Center
state: Iowa
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Clinton
country: United States
facility: MedStar Southern Maryland Hospital Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Dearborn
country: United States
facility: Ascension St. John
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital of Duluth
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Camden
country: United States
facility: Virtua Our Lady of Lourdes Hospital
state: New Jersey
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Bay Shore
country: United States
facility: Northwell Health - South Shore University Hospital
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Hospital
state: New York
city: Manhasset
country: United States
facility: Northwell Health - North Shore University Hospital
state: New York
city: New York
country: United States
facility: Northwell Health - Lennox Hill Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: West Islip
country: United States
facility: Good Samaritan University Hospital
state: New York
city: Raleigh
country: United States
facility: University of North Carolina Rex Hospital
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Seton Medical Center Austin
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Cologne
country: Germany
facility: St. Vinzenz Hospital
state: North Rhine Westphalia
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum NRW
state: NRW
city: Bad Segeberg
country: Germany
facility: Segerberger Kliniken
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Köpenik
city: Dachau
country: Germany
facility: Helios Amper-Klinikum Dachau
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Neuss
country: Germany
facility: Rheinland Klinikum
city: Rostock
country: Germany
facility: University Medicine Rostock
city: Athens
country: Greece
facility: General Hospital of Athens Hippokration
city: Magoúla
country: Greece
facility: Thriassion General Hospital
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Florence
country: Italy
facility: University Hospital Careggi
city: Messina
country: Italy
facility: University of Messina
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Danderyd University Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: Tyne And Wear
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: West Yorkshire
city: London
country: United Kingdom
facility: Imperial College Healthcare
Study officials:
affiliation: MedStar Health
name: Ronald Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shlofmitz E, Torguson R, Mintz GS, Zhang C, Sharp A, Hodgson JM, Shah B, Kumar G, Singh J, Inderbitzen B, Weintraub WS, Garcia-Garcia HM, Di Mario C, Waksman R. The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale. Am Heart J. 2020 Oct;228:65-71. doi: 10.1016/j.ahj.2020.08.002. Epub 2020 Aug 8.