Pulmonary Embolism (PE)
Conditions
Brief summary
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
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.
Interventions
DEVICEAcostream aspiration
The pulmonary thrombus removal by Acostream.
Sponsors
Xiamen Cardiovascular Hospital, Xiamen University
Nantong University Affiliated Hospital
Chengdu University of Traditional Chinese Medicine
Shanghai No.1 Hospital
First Affiliated Hospital of Fujian Medical University
Jinhua Central Hospital
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of RV/LV | 48 hours | The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pulmonary artery pressure before and after surgery | 48 hours | — |
| Changes in arterial oxygen pressure before and after surgery | 14 days | — |
| Surgical success rate | Immediately after surgery | — |
| All-cause mortality rate | 1, 3, 6, 12 months | — |
| Symptomatic PE recurrence rate | 1, 3, 6, 12 months | — |
| Clinical deterioration incidence | 48 hours | Clinical deterioration incidence includes tracheal intubation, mechanical ventilation, arterial hypotension\>1 hour or shock, cardiopulmonary resuscitation, significant deterioration of oxygenation, and emergency surgical thrombectomy) |
Countries
China
Contacts
Primary ContactQihong Ni
Backup ContactMeng Ye
Outcome results
None listed