MedTrace Logo

Mechanical Thrombectomy for Acute Pulmonary Embolism

NCT07032025 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-06-22

No results posted yet for this study

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.

Conditions

  • Acute Pulmonary Embolism

Interventions

PROCEDURE

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).

DRUG

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-07-01
Completion
2027-07-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07032025 on ClinicalTrials.gov