Trials / Recruiting
RecruitingNCT06365502
Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,860 (estimated)
- Sponsor
- Harbin Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Drug-coated balloon | Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed. |
| DRUG | Guideline-directed medical treatment | All individuals will receive guideline-directed medical treatment. |
Timeline
- Start date
- 2024-04-16
- Primary completion
- 2027-12-01
- Completion
- 2030-12-01
- First posted
- 2024-04-15
- Last updated
- 2024-05-22
Locations
18 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06365502. Inclusion in this directory is not an endorsement.