Trials / Not Yet Recruiting
Not Yet RecruitingNCT07510438
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease - A First-in-Human (FIH) Study
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Amplitude Vascular Systems, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulse Intravascular Lithotripsy (Pulse IVL) | The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of severely calcified stenotic de novo coronary arteries prior to stenting in patients with coronary artery disease. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2026-04-03
- Last updated
- 2026-04-03
Source: ClinicalTrials.gov record NCT07510438. Inclusion in this directory is not an endorsement.