Mechanical Thrombectomy for Acute Pulmonary Embolism
Status:
NOT_YET_RECRUITING
Trial end date:
2027-07-01
Target enrollment:
Participant gender:
Summary
Research Objective:
To prospectively compare the efficacy and safety of a pre-collaboratively developed ultra-thin PTFE minimally invasive thrombectomy system versus standard pharmacological therapy in patients with acute pulmonary embolism (PE), both administered on top of standard care.
Research Content:
Patients meeting all the following criteria will be enrolled:
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.
Study Design:
After confirming eligibility, subjects will be randomized at a 1:1 ratio into two groups:
Innovative Device Group: Minimally invasive thrombectomy
Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation
Study Endpoints:
Primary Efficacy Endpoint:
Reduction in RV/LV ratio (measured by CTPA) from baseline to 48 hours post-treatment.
Primary Safety Endpoint:
Incidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment, defined as:
Procedure-related death
Major bleeding (per VARC-2 criteria: life-threatening, disabling, or major bleeding)
Treatment-related clinical deterioration, including:
Unplanned mechanical ventilation
Arterial hypotension (systolic blood pressure \<90 mmHg for \>1 hour or requiring vasopressors) or shock
Cardiopulmonary resuscitation
Sustained deterioration in oxygenation
Emergency surgical embolectomy.
Key Terminology Notes:
RV/LV: Right Ventricular/Left Ventricular diameter ratio (standard medical abbreviation retained).
VARC-2: Valve Academic Research Consortium-2 (internationally recognized bleeding criteria).
PTFE: Polytetrafluoroethylene (material name preserved).
MAE: Major Adverse Events (acronym defined at first use).
Clinical deterioration: Explicitly specified with objective clinical indicators.
This translation maintains scientific precision while adhering to international clinical trial reporting standards (ICH-GCP). The structure aligns with typical English-language study protocols for clarity and reproducibility.