NCT06449274

RESTORE Imaging: an OCT-IVUS Imaging Substudy of RESTORE Trial

Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque: an OCT-IVUS Imaging Substudy (RESTORE Imaging)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this imaging substudy of RESTORE 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 plaque stabilization in patients with acute coronary syndrome.

Detailed description

The present study is an integrated imaging substudy of randomized, controlled and intervention trial of preventive drug-coated balloon angioplasty in vulnerable atherosclerotic plaque (RESTORE). The RESTORE Imaging trial will equally enroll from the DCB arm and GDMT arm to at least 180 consecutive individuals to validate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in enlarge luminal dimensions.

Conditions

• Acute Coronary Syndrome (ACS)

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. Individual will receive guideline-directed medical treatment.
DRUG	Guideline-directed medical treatment	All individuals will receive guideline-directed medical treatment.

Timeline

• Start date: 2024-06-25
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-06-07
• Last updated: 2024-07-15

Locations

1 site across 1 country: China