Trials / Unknown
UnknownNCT05606367
Coronary Non-slip Balloon Catheter in Patients With Coronary Artery Stenosis(CREST)
A Prospective, Randomized, Multicenter Clinical Trial of Non-slip Balloon Catheter in Patients With Coronary Artery Stenosis
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multicenter, randomized controlled clinical investigation aiming to evaluate the safety and effectiveness of non-slip balloon catheter for the treatment of patients with coronary artery stenosis.
Detailed description
This trial is a prospective, multicenter, randomized controlled clinical trial. 200 subjects are expected to be recruited in 7 research centers in China and randomly divided into two groups according to the ratio of test group: control group = 1:1. The primary endpoint is the acute lumen gain. All subjects receive clinical follow-up during hospitalization and 30 days after surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Non-slip Balloon Catheter of Shanghai MicroPort Rhythm | The principle of Non-slip Balloon Catheter in dilating stenotic lesions is mechanical extrusion of the vessel through the balloon, resulting in irregular rupture of atheromatous plaque and enlargement of the lumen. |
| DEVICE | NSE Coronary Dilatation Catheter | The Lacrosse® NSE is an angioplasty catheter with 3 longitudinal elements attached directly proximal and distal to the balloon that produces 3 endovascular surgical incisions during balloon dilation. |
Timeline
- Start date
- 2023-01-03
- Primary completion
- 2023-08-01
- Completion
- 2023-10-01
- First posted
- 2022-11-04
- Last updated
- 2023-04-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05606367. Inclusion in this directory is not an endorsement.