Pulmonary Embolism (PE)NCT06946732
Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism
A study testing Acostream aspiration in people with Pulmonary Embolism (PE), run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Embolism (PE)
- What is being tested?
- Acostream aspiration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200217
15801900772, niqihong1989@163.com
About this study
Official title: Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)
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.
Read the 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.
- Conditions
- Pulmonary Embolism (PE)
- Being tested
- Acostream aspiration
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acostream aspirationDevice
The pulmonary thrombus removal by Acostream.
| Study group | Role | What they receive |
|---|---|---|
| The Acostream aspiration group | Experimental | The pulmonary thrombus removal by Acostream. Receives: Device: Acostream aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of RV/LV
The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline
Measured: 48 hours
Secondary outcomes (6)
Surgical success rate
Measured: Immediately after surgery
Changes in pulmonary artery pressure before and after surgery
Measured: 48 hours
Changes in arterial oxygen pressure before and after surgery
Measured: 14 days
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)
Measured: 48 hours
All-cause mortality rate
Measured: 1, 3, 6, 12 months
Symptomatic PE recurrence rate
Measured: 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism (PE)Studies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946732
- Sponsor's protocol ID
- The ARTIST study
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)
- ClinicalTrials.gov ID
- NCT06946732
- Acronym / sponsor ID
- The ARTIST study
- Conditions
- Pulmonary Embolism (PE)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Acostream aspiration group | Experimental | Device: Acostream aspirationThe pulmonary thrombus removal by Acostream. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acostream aspirationThe pulmonary thrombus removal by Acostream. | Device | The Acostream aspiration group |
Primary outcome
Change of RV/LV
Time frame: 48 hours
The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline
6 secondary outcomes
Surgical success rate
Time frame: Immediately after surgery
Changes in pulmonary artery pressure before and after surgery
Time frame: 48 hours
Changes in arterial oxygen pressure before and after surgery
Time frame: 14 days
Clinical deterioration incidence
Time frame: 48 hours
All-cause mortality rate
Time frame: 1, 3, 6, 12 months
Symptomatic PE recurrence rate
Time frame: 1, 3, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acostream aspiration in people with Pulmonary Embolism (PE), run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qihong Ni (15801900772, niqihong1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of RV/LV (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.