Trials / Unknown
UnknownNCT05406869
Clinical Trials of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater
A Prospective, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater in the Treatment of Coronary Calcified Lesions
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The prospective, multicenter, single- arm study is designed to verify the safety and efficacy of pulsed sonic balloon dilatation catheter and pulsed sonic generater in the treatment of coronary calcification lesions.
Detailed description
The study will include a total of 170 patients with calcified coronary lesions who will be treated with pulsed sonic balloon dilatation catheter and pulsed sonic generater. Optical coherence tomography (OCT) imaging subgroups of 30 patients were designed in 1-2 centers to further accurately assess the treatment effect of calcified lesions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater | Deliver Pulsed Sonic Balloon Dilatation Catheter to the target vessel prior to placing a coronary stent or others |
Timeline
- Start date
- 2022-05-06
- Primary completion
- 2022-10-07
- Completion
- 2023-01-07
- First posted
- 2022-06-07
- Last updated
- 2022-06-07
Locations
14 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05406869. Inclusion in this directory is not an endorsement.