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The evaluation of the safety and efficacy of percutaneous mechanical pulmonary artery thrombectomy for acute pulmonary embolism

The evaluation of the safety and efficacy of percutaneous mechanical pulmonary artery thrombectomy for acute pulmonary embolism

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109345
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-01-02
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Pulmonary embolism (PE)

Interventions

Experimental group:Percutaneous mechanical pulmonary artery thrombectomy

Sponsors

The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.The participant or their guardian is aware of the nature of this study, agrees to participate, and has signed the consent form. 2.Age is between 18 and 85, regardless of gender. 3.Clinically diagnosed with symptomatic acute pulmonary embolism, with CT imaging indicating right - heart dysfunction (defined as an RV/LV ratio of 0.9 or higher). 4.The investigator has assessed that the participant is suitable for intra - vascular angiography and interventional therapy.

Exclusion criteria

Exclusion criteria: 1. Target vessel diameter is less than 6mm. 2.The target lesion has serious calcification, plaque, or stenosis. 3.Systolic blood pressure is below 90mmHg, or even with sufficient filling, vasopressors are needed to keep systolic pressure at or above 90mmHg, and the patient has end - organ hypoperfusion. 4.Systolic blood pressure is below 90mmHg or drops by 40mmHg or more for over 15 minutes, and this isn't due to new arrhythmia, low blood volume, or sepsis. 5.Patients with pulmonary artery systolic pressure over 70mmHg. 6.Hematocrit is less than 28%. 7.Patients with a history of chronic pulmonary arterial hypertension. 8.Patients with left bundle branch block. 9.A history of chronic left - sided heart failure and a left ventricular ejection fraction of 30% or less. 10. Abnormal kidney function (serum creatinine above 1.8mg/dL or above 159umol/L). 11.Known coagulation problems or a bleeding tendency (INR above 3). 12.Patients who can't take anti - platelet or anticoagulant therapy. 13.Had heart or lung surgery within 7 days before the procedure. 14.A pacemaker was implanted in the right atrium or right ventricle within 6 months before the procedure. 15.Patients with blood clots in the heart. 16.Patients receiving extracorporeal membrane oxygenation. 17.Known allergy to contrast agents. 18. Diseases that may make treatment and assessment difficult. 19.Pregnant and breastfeeding women. 20.Life expectancy of less than one month. 21.Taking part in other drug or medical device clinical trials. 22.Patients whom the investigator thinks are unsuitable for the trial.

Design outcomes

Primary

MeasureTime frame
Right ventricular end - diastolic inner diameter/left ventricular end - diastolic inner diameter (RV/LV);

Countries

China

Contacts

Public ContactMeng Xiaohu

The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

1193970654@qq.com+86 571 56007032

Outcome results

None listed

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