Mechanical Thrombectomy for Acute Pulmonary Embolism

Launched by RENJI HOSPITAL · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people who have a sudden blockage in one of the lungs’ blood vessels, called an acute pulmonary embolism (PE). The researchers want to see if using a very thin, minimally invasive device to remove the blockage (called a mechanical thrombectomy) works better and is as safe as the usual treatment with medicine that helps dissolve clots. Both treatments will be given alongside the standard care patients normally receive.

Adults between 18 and 75 years old who have been diagnosed with acute PE and show certain signs of heart strain on a special lung scan (a right to left heart size ratio of 0.9 or higher) may be eligible to join. If accepted, patients will be randomly assigned to either the new device treatment or the standard medicine treatment. The study will mainly look at how well each treatment reduces heart strain within two days and will carefully monitor for serious side effects, like major bleeding or worsening breathing problems. It’s important to know that some people won’t qualify, such as those with very low blood pressure, certain heart or kidney problems, or other health issues that could make the treatments risky. This study is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18-75 years (male or female)
• • Clinically diagnosed with acute PE
• • Right ventricular/left ventricular diameter ratio (RV/LV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)
• • Provision of voluntary written informed consent.
• Exclusion Criteria:
• • Target vessel diameter \<6 mm
• • Calcification, plaque, or stenosis in target lesion
• • Sustained systolic blood pressure \<90 mmHg for \>15 minutes or requiring vasopressors to maintain SBP ≥90 mmHg
• • Peak pulmonary artery pressure \>70 mmHg
• • Hematocrit \<28%
• • History of chronic pulmonary hypertension
• • Pre-existing left bundle branch block
• • Chronic left heart failure with left ventricular ejection fraction (LVEF) ≤30%
• • Renal dysfunction (serum creatinine \>1.8 mg/dL or \>159 μmol/L)
• * Known coagulopathy or bleeding diathesis:
• • Platelet count \<50×10⁹/L, or International Normalized Ratio (INR) \>3
• • Contraindications to antiplatelet/anticoagulant therapy
• • Cardiothoracic or pulmonary surgery within 7 days prior
• • Intracardiac thrombus
• • Patients on extracorporeal membrane oxygenation (ECMO)
• • Known hypersensitivity to iodinated contrast media
• * Significant comorbidities complicating treatment/evaluation:
• • Active malignancy Acute infectious disease/sepsis Systemic conditions precluding procedure tolerance Life expectancy \<1 year
• • Pregnant or lactating women
• • Concurrent participation in other drug/device trials
• • Other investigator-determined unsuitability