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

Atherosclerosis Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04221815
• Other study ID #: IMPROVE
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: August 2027

Study information

• Verified date: May 2024
• Source: Medstar Health Research Institute
• Contact: Shreejana Pokharel
• Phone: 2409417922
• Email: shreejana.pokharel[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3100
• Est. completion date: August 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Device:
• Eagle Eye Platinum digital IVUS catheter with optional SyncVision
IVUS catheter
• Resolute Onyx Drug Eluting Stent
Stent
• Onyx Frontier Drug Eluting Stent
Stent
• Onyx TruStar Drug Eluting Stent
Stent
• Onyx TruCor Drug Eluting Stent
Stent

Locations

Country	Name	City	State
Germany	Herz-und Diabeteszentrum NRW	Bad Oeynhausen	NRW
Germany	Segerberger Kliniken	Bad Segeberg
Germany	DRK Kliniken Berlin Köpenik	Berlin
Germany	St. Vinzenz Hospital	Cologne	North Rhine Westphalia
Germany	Helios Amper-Klinikum Dachau	Dachau
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Rheinland Klinikum	Neuss
Germany	University Medicine Rostock	Rostock
Greece	General Hospital of Athens Hippokration	Athens
Greece	Thriassion General Hospital	Magoúla
Israel	Shamir Medical Center	Be'er Ya'aqov
Israel	Meir Medical Center	Kfar Saba
Italy	University Hospital Careggi	Florence
Italy	University of Messina	Messina
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Skane University Hospital	Lund
Sweden	Danderyd University Hospital	Stockholm
United Kingdom	Leeds General Infirmary	Leeds	West Yorkshire
United Kingdom	Imperial College Healthcare	London
United Kingdom	Freeman Hospital	Newcastle Upon Tyne	Tyne And Wear
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Emory	Atlanta	Georgia
United States	Seton Medical Center Austin	Austin	Texas
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Northwell Health - South Shore University Hospital	Bay Shore	New York
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	NYU Langone Hospital	Brooklyn	New York
United States	Virtua Our Lady of Lourdes Hospital	Camden	New Jersey
United States	Rush University Medial Center	Chicago	Illinois
United States	MedStar Southern Maryland Hospital Center	Clinton	Maryland
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Ascension St. John	Dearborn	Michigan
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	MercyOne Iowa Heart Center	Des Moines	Iowa
United States	St. Luke's Hospital of Duluth	Duluth	Minnesota
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Riverside Medical Center	Kankakee	Illinois
United States	University of California San Deigo	La Jolla	California
United States	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas
United States	Northwell Health - North Shore University Hospital	Manhasset	New York
United States	University of Minnesota	Minneapolis	Minnesota
United States	Northwell Health - Lennox Hill Hospital	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Ascension Sacred Heart	Pensacola	Florida
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	University of North Carolina Rex Hospital	Raleigh	North Carolina
United States	Carilion Clinic	Roanoke	Virginia
United States	St. Francis	Roslyn	New York
United States	San Francisco VA Health Care System	San Francisco	California
United States	AdventHealth Sebring	Sebring	Florida
United States	Baystate Medical Center	Springfield	Massachusetts
United States	SUNY Upstate Medical Center	Syracuse	New York
United States	Tampa Cardiovascular/St. Joseph's Hospital	Tampa	Florida
United States	Northwest Medical Center	Tucson	Arizona
United States	San Antonio Regional Hospital	Upland	California
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Good Samaritan University Hospital	West Islip	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Countries where clinical trial is conducted

United States,  Germany,  Greece,  Israel,  Italy,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IVUS core lab measures final PCI Minimum Stent Area	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.	Intra-procedural
Primary	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.	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.	12 months