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Comparative Study on Effectiveness and Safety of Domestic versus Imported Intra-Aortic Balloon Pump Counterpulsation Systems

Comparative Study on Effectiveness and Safety of Domestic versus Imported Intra-Aortic Balloon Pump Counterpulsation Systems

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123599
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Cardiogenic shock/Complex coronary artery disease PCI surgery requires IABP-assisted circulatory support

Interventions

A:Domestic Aortic balloon pump (IABP) balloon catheter
B:Imported Aortic balloon pump (IABP) balloon catheter

Sponsors

General Hospital of Southern Theatre Command, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Patients with acute myocardial infarction or fulminant myocarditis or dilated cardiomyopathy complicated 1.with cardiogenic shock (cardiogenic shock in stage B or C) or complex coronary artery disease who need IABP-assisted circulatory support during PCI surgery, or patients who need IABP-assisted circulatory support for other reasons; 2.Sinus rhythm; 3. Age: 14 to 85 years old.

Exclusion criteria

Exclusion criteria: 1.Patients after thrombolysis; 2. Contraindications for anticoagulation; 3. Femoral artery puncture failed; 4. Unstable electrocardiogram after cardiopulmonary resuscitation; 5. Moderate or severe aortic valve regurgitation; 6. Aortic dissection or aortic aneurysm; 7. Severe infection; 8. Age 85 years old; 9. Those who plan or expect to need the combined use of multiple circulatory adjuvant support treatments; 10. The researchers believe that it is not suitable for selection.

Design outcomes

Primary

MeasureTime frame
Backlash pressure difference value;The systolic pressure difference within the aorta;

Secondary

MeasureTime frame
Peripheral non-invasive brachial artery systolic pressure difference;The difference between systolic and diastolic blood pressure within the aorta;Success rate of catheter implantation;The difference in stroke volume;Left ventricular ejection fraction(LVEF);Maximum velocity of the aortic valve;

Countries

China

Contacts

Public ContactDingcheng Xiang

General Hospital of Southern Theatre Command, PLA

dcxiang@foxmail.com+86 136 0900 8024

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026