Trials / Unknown
UnknownNCT03625830
The Efficacy and Safety of SeQuent® Please in the Treatment of Small Vessel Disease (SVD) Patient
A Randomized, Multicenter Study on the Efficacy and Safety of Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) Compared to POBA in the Treatment of Small Vessel Disease (SVD) Patient
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- B. Braun Medical International Trading Company Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to evaluate the safety and effectiveness of paclitaxel-releasing coronary balloon (Catheter SeQuent® Please) versus rapid exchange PTCA balloon catheter (SeQuent® Neo) in the treatment of stenoses of coronary small vessels. 270 subjects will be enrolled for the trials.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) | SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial. |
| DEVICE | rapid exchange PTCA -Balloon Catheter (SeQuent® Neo) | SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial. |
Timeline
- Start date
- 2017-12-18
- Primary completion
- 2019-08-30
- Completion
- 2019-12-30
- First posted
- 2018-08-10
- Last updated
- 2019-01-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03625830. Inclusion in this directory is not an endorsement.