SOLSTICE Trial in China
NCT05433376 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-06-27
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
- Coronary Artery Disease
- Calcifications Vascular
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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