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Microcirculatory Status After Intravascular Lithotripsy

NCT05134051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-07-25

No results posted yet for this study

Summary

Due to differences in the mechanism of action, intravascular lithotripsy is likely to cause less distal embolization and microcirculatory dysfunction during plaque preparation. This may also translate into lower periprocedural myocardial infarction rates. Thus, this exploratory study aims to evaluate the microcirculatory function after the use of Shockwave® intravascular lithotripsy.

Conditions

Interventions

DEVICE

Shockwave® Intravascular Lithotripsy System (Shockwave Medical Inc)

IVL is a novel balloon catheter-based device that utilises pulsatile mechanical energy to disrupt calcified lesions. IVL differs from other types of lithotripsy with respect to depth of penetration. It is a single-use, sterile, disposable balloon catheter. The emitters convert electrical energy into transient acoustic circumferential pressure pulses that disrupt both superficial and deep calcium within plaque. The balloon catheter is connected to the generator, which is programmed to deliver the specified dosage of pulses. The IVL balloon, sized 1:1 to the reference artery ratio, is inflated low pressure (4 atm) with 10 pulses of ultrasound energy of 10s delivered per balloon. The procedure is repeated to provide a minimum of 20 pulses in the target lesion, with interval deflation to allow distal perfusion. Each catheter can emit a max of 80 pulses at a rate of one pulse per second. If the lesion exceeds the 12mm balloon length, the balloon can be repositioned and the IVL repeated.

Sponsors & Collaborators

  • Cardiac Research Institute BV

    lead OTHER

Principal Investigators

  • Carlos Collet · Cardiovascular Center OLV Aalst

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2021-12-01
Completion
2021-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT05134051 on ClinicalTrials.gov