The safety and efficacy of optical coherence tomography (OCT) guided drug-coated balloon combined with drug therapy compared with drug therapy on coronary vulnerable plaque

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400093251

Enrollment

Unknown

Registered

2024-11-29

Start date

2024-12-01

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery diseases

Interventions

Intervention group:Drug-coated balloon combined with drug therapy

Control group:Drug therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The reference vessel diameter for the target lesion is between 2.75mm and 4.00mm; 2. The length of the target lesion is = 25mm and there is a single lesion in a single vessel or one lesion in each of two vessels; 3. 2 out of 4 OCT features are met: Minimum lumen area (MLA)180 °; Fiber cap thickness<75µm; Macrophage aggregation.

Exclusion criteria

Exclusion criteria: 1. Chronic total occlusion; 2. Left main disease; 3. Branching lesions that require double stenting; 4. Moderate to severe coronary artery tortuosity, angle formation, or severe calcification lesions

Design outcomes

Primary

Measure	Time frame
Late lumen loss;	—

Secondary

Measure	Time frame
Clinical events: target lesion failure, patient-centered composite endpoints, clear or potential thrombotic events, major bleeding events, readmission due to angina pectoris, and stroke events;	—

Countries

China

Contacts

Public ContactZhao Xin

The first affiliated hospital of Soochow University

ingram_zhang@163.com+86 137 7192 7060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026