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

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04221815
• Collaborator: (none)
• Enrollment: 3,100
• Locations: 23
• Arms: 2
• Anticipated Duration (Months): 57.6
• Patients Per Site: 134.8
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 14, 2020
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IVUS guided PCI Patients will receive 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

Outcome Measures

Primary Outcome Measures

1. 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.

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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Deigo	La Jolla	California	United States	92037
2	San Antonio Regional Hospital	Upland	California	United States	91786
3	Medstar Washington Hospital Center	Washington	District of Columbia	United States	20010
4	Manatee Memorial Hospital	Bradenton	Florida	United States	34205
5	AdventHealth Orlando	Orlando	Florida	United States	32803
6	Ascension Sacred Heart	Pensacola	Florida	United States	32504
7	Tampa Cardiovascular/St. Joseph's Hospital	Tampa	Florida	United States	33614
8	Emory	Atlanta	Georgia	United States	30322
9	Atlanta VA Medical Center	Decatur	Georgia	United States	30033
10	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
11	Carle Foundation Hospital	Urbana	Illinois	United States	61801
12	MercyOne Iowa Heart Center	Des Moines	Iowa	United States	50314
13	AtlantiCare Regional Medical Center	Pomona	New Jersey	United States	08240
14	Northwell Health - South Shore University Hospital	Bay Shore	New York	United States	11706
15	Northwell Health - North Shore University Hospital	Manhasset	New York	United States	11030
16	Northwell Health - Lennox Hill Hospital	New York	New York	United States	10075
17	SUNY Upstate Medical Center	Syracuse	New York	United States	13210
18	The Ohio State University Medical Center	Columbus	Ohio	United States	43201
19	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
20	Seton Medical Center Austin	Austin	Texas	United States	78705
21	DRK Kliniken Berlin Köpenik	Berlin		Germany	12559
22	Helios Amper-Klinikum Dachau	Dachau		Germany	85221
23	Skane University Hospital	Lund		Sweden	22185

Sponsors and Collaborators

• Medstar Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT04221815
• Other Study ID Numbers: IMPROVE
• First Posted: Jan 9, 2020
• Last Update Posted: Jun 10, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Atherosclerosis

Study Results

No Results Posted as of Jun 10, 2022