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Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism

ConditionPulmonary Embolism (PE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorRenJi Hospital

About this trial

The registry is to evaluate the safety and feasibility of catheter-directed aspiration for patients with high-risk and intermediate-high-risk pulmonary embolism using Acostream.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18≤Age≤85

Clinical symptoms and presentation consistent with pulmonary embolism (PE).

PE symptoms duration ≤ 14 days.

High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.

Disqualifiers

Pregnancy.

Refusal to sign the informed consent form.

Presence of intracardiac thrombus.

Presence of chronic left heart failure with an ejection fraction lower than 30% Diagnosed thrombophilia.

Trial design

Design model

Single group

Treatments tested in this trial

  • Acostream aspiration

    Device

    The pulmonary thrombus removal by Acostream.

Treatment groups

127 Participants
are divided into 1 treatment group
Group A: The Acostream aspiration groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change of RV/LV

The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline

Time frame
48 hours

Secondary outcomes

1

Surgical success rate

Time frame
Immediately after surgery
2

Changes in pulmonary artery pressure before and after surgery

Time frame
48 hours
3

Changes in arterial oxygen pressure before and after surgery

Time frame
14 days
4

Clinical deterioration incidence

Clinical deterioration incidence includes tracheal intubation, mechanical ventilation, arterial hypotension\>1 hour or shock, cardiopulmonary resuscitation, significant deterioration of oxygenation, and emergency surgical thrombectomy)

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Xiamen Cardiovascular Hospital, Xiamen University

Collaborator

Nantong University Affiliated Hospital

Collaborator

Chengdu University of Traditional Chinese Medicine

Collaborator

Shanghai No.1 Hospital

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

Jinhua Central Hospital

Collaborator

Source ClinicalTrials.gov
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