Mechanical Thrombectomy for Acute Pulmonary Embolism

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.