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Evaluating the safety and efficacy of drug balloon prophylactic treatment of non-offender vulnerable plaques in acute coronary syndrome: a prospective, multicenter, randomized controlled study

Evaluating the safety and efficacy of drug balloon prophylactic treatment of non-offender vulnerable plaques in acute coronary syndrome: a prospective, multicenter, randomized controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100199
Enrollment
Unknown
Registered
2025-04-03
Start date
2024-04-16
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

ACS patients with non-criminal vulnerable plaque characteristics

Interventions

Experimental group:Drug-eluting balloon + standard drug therapy group
Control group:Standard drug treatment group

Sponsors

The Second Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Subject 18 years old 0.8; (5) Non-criminal plaques meet any two requirements of IVUS-PB>65%, OCT-MLA180°; (6) Agree to join the group and sign a written informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who are allergic to aspirin, clopidogrel, ticagrelor, heparin, contrast agent and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases; (2) hypotension, shock, or the need for mechanical support or intravenous vasopressors; (3) Patients with a history of severe renal insufficiency; (4) Pregnant or lactating women; (5) Subjects with EF 30%; (3) The target lesions were bifurcated lesions, with branch vessel diameter >2mm and stenosis >50%. (4) The angiography showed serious calcification or tortuosity of the vessel where the target lesion was located; (5) Lesions involving the opening of the LAD, LCX, or RCA (within 3mm of the opening); (6) The target lesions were located in the pontine vessels.

Design outcomes

Primary

MeasureTime frame
OCT/IVUS/OCT-IVS;MACE;

Secondary

MeasureTime frame
blood routine examination;blood biochemistry;Markers of myocardial injury;BNP/NT-proBNP;glycosylated hemoglobin;ECG;ultrasonic cardiogram;CAG;

Countries

China

Contacts

Public ContactBo Yu

The Second Affiliated Hospital of Harbin Medical University

yubodr@163.com+86 138 0458 5601

Outcome results

None listed

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