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

NCT ID: NCT06946732

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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The registry is a prospective, multicenter, observational study involving 130 patients across up to seven sites in China. The aim of this study is to evaluate the safety and feasibility of catheter-directed thrombectomy using Acostream in patients with high-risk and intermediate-high-risk pulmonary embolism. The primary endpoint of the study is the efficacy and safety of pulmonary thrombus removal, assessed by reduction of ventricular strain, decrease in vascular obstruction, overall clinical improvement, and the early mortality rate from pulmonary embolism. Secondary endpoints include the total mortality rate of PE and the incidence of complications in the procedure.

Conditions

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Pulmonary Embolism (PE)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The Acostream aspiration group

The pulmonary thrombus removal by Acostream.

Group Type EXPERIMENTAL

Acostream aspiration

Intervention Type DEVICE

The pulmonary thrombus removal by Acostream.

Interventions

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Acostream aspiration

The pulmonary thrombus removal by Acostream.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.
* Intermediate-high risk PE patients with right ventricle dysfunction (right ventricle/ left ventricle \>0.9) confirmed by computed tomography pulmonary angiography or transthoracic echocardiography.

Exclusion Criteria

* 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.
* History of severe or chronic pulmonary hypertension.
* Serum creatinine level higher than 1.8 mg/dl.
* Known serious and uncontrolled sensitivity to radiographic agents.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiamen Cardiovascular Hospital, Xiamen University

OTHER

Sponsor Role collaborator

Nantong University Affiliated Hospital

UNKNOWN

Sponsor Role collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Shanghai No.1 Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Jinhua Central Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qihong Ni

Role: CONTACT

15801900772

Meng Ye

Role: CONTACT

13817145123

Facility Contacts

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Role: primary

15801900772

Other Identifiers

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The ARTIST study

Identifier Type: -

Identifier Source: org_study_id

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