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Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT

NCT05973994 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-08-03

No results posted yet for this study

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.

Conditions

  • Coronary Artery Calcification

Interventions

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.

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Giuseppe M Sangiorgi, Professor · University of Rome Tor Vergata

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2023-12-31
Completion
2024-06-30
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973994 on ClinicalTrials.gov