NCT05973994

Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational, prospective, multicenter study is to explore local action of coronary calcium fragmentation exerted by endovascular lithotripsy by images acquired with OCT, in patients with coronary artery calcifications responsible for significant stenosis, candidate to PCI. The main question it aims to answer, is the ability of Shockwave System to reduce calcium density in the Region of Interest (ROI) of the vessel wall.

Detailed description

Coronary arteries with calcific lesions will undergo intravasculary lithotripsy (IVL) treatment; OCT acquisition will be performed before IVL treatment, after IVL treatment and after stent-implantation. All OCT frames will be uploaded on the image processing and analysis program ImageJ (US National Institutes of Health). ROI will be selected as part of image where calcium is located. Image analysis will be performed using frequency histogram of pixel density in the ROI pre- and post-IVL, as a measure of calcium density. Mean pixel density of the ROI before IVL will be compared with mean pixel density of the ROI after IVL, measuring delta pixel density.

Conditions

• Coronary Artery Calcification

Interventions

Type	Name	Description
DEVICE	intravascular lithotripsy with Shockwave coronary system	OCT acquistion is performed at baseline. Then the IVL catheter will be passed across the lesion over the guidewire. Atherectomy or cutting/scoring balloons is not permitted per protocol. The IVL procedure is considered successful when a residual stenosis \<50% by visual estimate after IVL alone is achieved. After IVL procedure, one OCT imaging acquisition must be performed. If the residual stenosis is ≥50% following IVL, noncompliant balloon dilatation will be performed prior to stenting and OCT images repeated accordingly. Subsequent stent implantation will be performed per local standard of care at the discretion of the operator. Following stent implantation, high pressure post-dilatation is recommended and OCT imaging acquisition must be performed to assess stent apposition for secondary end point.

Timeline

• Start date: 2022-02-21
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2023-08-03
• Last updated: 2023-08-03

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study