Trials / Completed
CompletedNCT04151628
Disrupt CAD IV With the Shockwave Coronary IVL System
Prospective, Multicenter, Single-Arm Study of the SWM-1234 in Calcified Coronary Arteries (Disrupt CAD IV Study - Japan)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Shockwave Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting.
Detailed description
Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention. Approximately 72 subjects at 8 sites in Japan will be enrolled. Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lithotripsy | Deliver Lithotripsy to the target vessel prior to placing a coronary stent |
Timeline
- Start date
- 2019-11-06
- Primary completion
- 2020-05-08
- Completion
- 2022-03-25
- First posted
- 2019-11-05
- Last updated
- 2023-05-22
- Results posted
- 2021-06-25
Locations
8 sites across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04151628. Inclusion in this directory is not an endorsement.