IMPROVE
Research type
Research Study
Full title
IMPact on Revascularization Outcomes of intraVascular ultrasound guided treatment of complex lesions and Economic impact (IMPROVE)
IRAS ID
303238
Contact name
Richard A Anderson
Contact email
Sponsor organisation
MedStar Cardiovascular Research Network
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV ID, CIV-21-11-038108
Duration of Study in the UK
3 years, 1 months, 31 days
Research summary
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.
The objective of this clinical trial is to demonstrate the superiority of an Intravascular Ultrasound (IVUS) - guided stent implantation strategy compared to an angiography-guided stent implantation strategy in achieving larger post-percutaneous coronary intervention (PCI) stent/lumen dimensions and improving clinical cardiovascular outcomes in patients with complex angiographic lesions.
We hypothesize that the impact of IVUS in these complex lesions is of increased importance in reducing long-term clinical adverse events.REC name
Wales REC 2
REC reference
23/WA/0007
Date of REC Opinion
22 Mar 2023
REC opinion
Further Information Favourable Opinion