Trials / Completed
CompletedNCT03373695
A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis
A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 260 (actual)
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dissolve™ | Dissolve™ are to be used in the trial |
| DEVICE | SeQuent®Please | SeQuent®Please are to be used in the trial |
Timeline
- Start date
- 2018-02-22
- Primary completion
- 2020-01-09
- Completion
- 2024-04-24
- First posted
- 2017-12-14
- Last updated
- 2025-02-20
Locations
15 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03373695. Inclusion in this directory is not an endorsement.