Trials / Unknown
UnknownNCT05433376
SOLSTICE Trial in China
Clinical Trial of the ShOckwave Coronary Intravascular Lithotripsy (IVL) System Used to Treat CalcIfied Coronary ArtEries (SOLSTICE)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Genesis Medtech Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Shockwave Coronary Intravascular Lithotripsy (IVL) System C2 | lithotripsy-enabled, low-pressure dilatation balloon to modify severely calcified lesions |
Timeline
- Start date
- 2021-04-15
- Primary completion
- 2021-11-25
- Completion
- 2022-11-26
- First posted
- 2022-06-27
- Last updated
- 2022-06-27
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05433376. Inclusion in this directory is not an endorsement.