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SOLUTION Trial in China

NCT05434676 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-28

No results posted yet for this study

Summary

This is a prospective, multicenter, single arm study, to support the safety and effectiveness assessment of the Shockwave Medical Peripheral IVL System applied to Chinese patients

Conditions

  • Peripheral Arterial Disease
  • Calcifications Vascular

Interventions

DEVICE

Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4

To assess the safety and effectiveness of IVL treatment used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries

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
2021-06-15
Primary Completion
2022-01-30
Completion
2023-07-30

Countries

  • China

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 NCT05434676 on ClinicalTrials.gov