Trials / Completed
CompletedNCT05998252
Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
A Post-Market Study to Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- BrosMed Medical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, single-group study aims to evaluate the safety and efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI, and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up of the subjects will be recorded, and the safety and efficacy of the investigational device will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Alveo HP Balloon Dilatation Catheter | Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery. |
Timeline
- Start date
- 2022-12-27
- Primary completion
- 2023-08-29
- Completion
- 2023-12-08
- First posted
- 2023-08-18
- Last updated
- 2024-01-10
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05998252. Inclusion in this directory is not an endorsement.