Trials / Completed
CompletedNCT05250193
DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA)
A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of DK ScoreTM Scoring Balloon Vesus Non-Slip Element Coronary Dilatation Catheter for Coronary Artery Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, Multi-center, Randomized Study designed to evaluate the acute lumen gain and device procedural success of the DK ScoreTM Scoring balloon versus NSE Scoring Balloon for patients with coronary arteries stenosis.
Detailed description
This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate Acute Lumen Gain after dilatation. A total of 200 patients will be enrolled from 4 sites in China. All patients enrolled will be randomly assigned to the test group (DK ScoreTM group, n=100) and the control group (NSE group, n=100) with randomized allocation ratio of 1:1. Patients in the test group and the control group will be treated with DK ScoreTM Scoring balloon catheters or NSE Coronary Dilatation Catheter. A 30-day after procedure follow-up will be conducted for all 200 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DK ScoreTM Coronary Scoring Balloon | After pre-dilation balloon is used (if any), DK Score is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment. |
| DEVICE | Non-Slip Element Coronary Dilatation Catheter | After pre-dilation balloon is used (if any), NSE is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment. |
Timeline
- Start date
- 2021-03-24
- Primary completion
- 2021-09-02
- Completion
- 2021-12-30
- First posted
- 2022-02-22
- Last updated
- 2022-03-10
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05250193. Inclusion in this directory is not an endorsement.