Trials / Completed
CompletedNCT06214247
Wedge NC - Scoring Balloon Dilatation Catheter
A Prospective, Open Label, Multi-center, Randomized Study Designed to Evaluate the Safety and Efficacy of Scoring PTCA Catheter on Subjects During Percutaneous Coronary Intervention
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 198 (actual)
- Sponsor
- BrosMed Medical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter for dilating coronary stenosis during PCI in comparison with a similar product on the market.
Detailed description
The prospective, multicenter, open-label, randomized clinical study is designed to verify the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter in the application of dilatating coronary artery stenosis during PCI in comparison with a similar product on the market. The study is planned to enroll 198 subjects, who are randomly assigned to the test group (99 cases) and the control group (99 cases).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Wedge NC Scoring Balloon Dilatation Catheter | During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Wedge NC Scoring Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure. |
| DEVICE | Scoreflex Scoring Balloon Dilatation Catheter | During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using a similar product on the market in the control group, subsequently completing the remaining procedure. |
Timeline
- Start date
- 2021-08-27
- Primary completion
- 2022-02-28
- Completion
- 2022-05-17
- First posted
- 2024-01-19
- Last updated
- 2024-01-19
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06214247. Inclusion in this directory is not an endorsement.