Trials / Completed
CompletedNCT03376646
A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease
A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to Resolute™ Integrity in Treatment of Coronary Small Vessel Disease in Chinese Population
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 277 (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 in the treatment of Coronary Small Vessel Disease by drug coated balloon (DCB) Dissolve™ versus drug eluting stent (DES) Resolute™ Integrity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cohort A: Dissolve™ | Dissolve™ are to be used in the trial |
| DEVICE | Cohort A: Resolute™ Integrity | Resolute™ Integrity are to be used in the trial |
| DEVICE | Cohort B: Dissolve™-2.00mm | Dissolve™ are to be used in the trial |
Timeline
- Start date
- 2018-06-20
- Primary completion
- 2020-01-10
- Completion
- 2024-04-15
- First posted
- 2017-12-18
- Last updated
- 2025-02-20
Locations
15 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03376646. Inclusion in this directory is not an endorsement.