NCT07514988

Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

Comparison Study of Sirolimus-Coated Versus Paclitaxel-Coated Coronary Drug-Coated Balloons in the Treatment of Acute Coronary Syndrome

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.

Detailed description

This prospective, single-center, randomized, controlled trial aims to evaluate and compare the differential effects of sirolimus-coated versus paclitaxel-coated drug-coated balloons (DCBs) on local inflammatory responses and plaque healing characteristics in patients with acute coronary syndrome (ACS) with optical coherence tomography (OCT).

Conditions

• Acute Coronary Syndromes (ACS)

Interventions

Type	Name	Description
DEVICE	Sirolimus-coated DCB	Treatment of sirolimus-coated DCB
DEVICE	Paclitaxel-coated DCB	Treatment of paclitaxel-coated DCB

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-12-31
• Completion: 2028-07-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: China