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A randomized controlled study of the effectiveness of percutaneous pulmonary thrombotic tissue aspiration in improving pulmonary blood flow grading in patients with chronic thromboembolic pulmonary hypertension

A randomized controlled study of the effectiveness of percutaneous pulmonary thrombotic tissue aspiration in improving pulmonary blood flow grading in patients with chronic thromboembolic pulmonary hypertension

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052570
Enrollment
Unknown
Registered
2021-10-31
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Interventions

Control group:Traditional simple BPA procedure
Experimental group:Traditional simple BPA + thrombotic tissue removal

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18-80 years; 2. CTEPH patients with definite diagnosis: after more than 3 months of standardized anticoagulant therapy, chronic pulmonary artery thrombosis was confirmed by imaging, and mPAP >= 25mmHg and PAWP <= 15mmHg were confirmed by right cardiac catheterization, except for other similar embolic diseases, such as vasculitis, pulmonary artery sarcoma, fibrinoid mediastinum, congenital pulmonary artery stenosis, etc.; 3. Comply with any of the following standards: (1) Pulmonary endarterectomy (PEA) cannot be performed due to contraindication; (2) Not suitable for pulmonary endarterectomy (PEA); (3) Persistent or recurrent pulmonary hypertension after receiving PEA. 4. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe heart failure or grade IV heart function; 2. severe systemic infection or fever; 3. Severe renal insufficiency; 4. Severe anemia or active bleeding; 5. Patients who cannot tolerate anticoagulant therapy; 6. People who are mentally ill and cannot cooperate with the operation; 7. People allergic to iodine contrast agent; 8. Participated in any other experiment within 4 weeks.

Design outcomes

Primary

MeasureTime frame
Pulmonary Angiography Pulmonary Flow Grading (PFG);

Secondary

MeasureTime frame
Peripheral oxygen saturation;NT-proBNP;6 minutes walking distance (6MWD);Chest radiograph and lung CT;Echocardiography;Right cardiac catheter hemodynamic data (PAP, RAP, PAWP, PVR, CI, CO, SvO2);Histopathological examination of aspiration thrombus;

Countries

China

Contacts

Public ContactGuo Tingting, Hua Lu

Fuwai Hospital, Chinese Academy of Medical Sciences

18610094559@163.com+86 18610094559,+86 13681556900,?

Outcome results

None listed

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