NCT06416813

Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques

Preventive Intervention Value of Drug-Coated Balloons in Vulnerable Coronary Atherosclerotic Plaques

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Yong He · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PASSIVATE-CAP study is an investigator-initiated, prospective, randomized, multicenter, open-label superiority trial focusing on acute coronary syndrome (ACS) patients with nonflow-limiting vulnerable plaques in nonculprit vessels. In this study, eligible patients were randomized at a 1:1 ratio into two groups: patients who received guideline-directed medical therapy (GDMT) and patients who received GDMT combined with a drug-coated balloon (DCB). In this study, the use of PCSK9 inhibitors was limited to inclisiran. The primary endpoint was the minimal lumen area of the target lesion 1 year after randomization. The secondary endpoints encompass a range of factors, including the proportion of patients with vulnerable plaques in the target vessel, fibrous cap thickness, lipid core arc of the target lesion, minimal lumen area of the target vessel, and extent of LDL-C reduction in patients treated with inclisiran.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	GDMT+DCB	Preventive Intervention on Eligible Vulnerable Plaques Using DCB

Timeline

• Start date: 2025-06-06
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2024-05-16
• Last updated: 2025-09-08

Locations

1 site across 1 country: China