Clinical Research Directory
Browse clinical research sites, groups, and studies.
Mechanical Thrombectomy for Acute Pulmonary Embolism
Sponsor: RenJi Hospital
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.
Official title: A Prospective, Multicenter, Randomized Controlled Trial of the Catheter-directed Mechanical Thrombectomy Compared to Standard Anticoagulation for Use in the Treatment of Acute Intermediate-risk Pulmonary Embolism.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-07-01
Completion Date
2027-07-01
Last Updated
2025-06-22
Healthy Volunteers
No
Conditions
Interventions
Innovative Device Group
Catheter-based thrombectomy is performed within 4 hours after baseline CTPA acquisition. Pre-procedural anticoagulation with either low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) is administered prior to thrombectomy. Post-procedural oral anticoagulation is transitioned to rivaroxaban 20 mg once daily (QD).
Standard Pharmacological Therapy Group
Following thrombolytic agent administration, anticoagulation with rivaroxaban is initiated and maintained at 15 mg twice daily (BID) for the initial 3 weeks, then switched to 20 mg once daily (QD) thereafter.