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Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter

NCT05732025 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-02-16

No results posted yet for this study

Summary

Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Severely calcified lesions, or severely calcified lesions with twisted, angulated, diffused, significantly increase rates of immediate complications and early and late major adverse cardiovascular events. Correctly identifying and evaluating calcified lesions, and selecting the most appropriate treatment strategy according to the degree of coronary artery calcification are very important for improving the success rate of intervention, reducing complications, and improving the short-term and long-term prognosis of patients.

Conditions

  • Calcified Atheroma

Interventions

DEVICE

Electrohydraulic shock wave lithotripsy

Pre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy

DEVICE

Rotary atherectomy

Pre-treatment of severe calcified coronary lesions with rotary atherectomy

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Jian-an Wang, MD,PhD · Second Affiliated Hospital of Zhejiang University, School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-10-31
Completion
2023-12-31

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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 NCT05732025 on ClinicalTrials.gov