SOLSTICE Trial in China

NCT05433376 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-27

No results posted yet for this study

Summary

This is a small sample size clinical trial in Chinese population to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

Conditions

Interventions

DEVICE

Shockwave Coronary Intravascular Lithotripsy (IVL) System C2

lithotripsy-enabled, low-pressure dilatation balloon to modify severely calcified lesions

Sponsors & Collaborators

  • Genesis Medtech Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2021-11-25
Completion
2022-11-26

Countries

  • China

Study Locations

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Entities

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 NCT05433376 on ClinicalTrials.gov