PE - Pulmonary EmbolismSRAMENCT05992168
Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)
A study testing Stent-Retriever in people with PE - Pulmonary Embolism and PE - Pulmonary Thromboembolism, run by Suzhou Zenith Vascular SciTech Limited at 1 site in China.
Trial summary
To evaluate treatment outcomes of patients diagnosed with pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
- What is being tested?
- Stent-Retriever
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2024to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18≤ age ≤75, no gender limitation; 2.patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance; 3.RV/LV ratio ≥0.9; 4.Patients who agreed to participate in the study and voluntarily signed the informed consent.
Who cannot join
- Patients with systolic blood pressure<90 mmHg and lasting for 15 minutes or requiring maintenance of systolic blood pressure ≥ 90 mmHg;
- Patients with known severe pulmonary hypertension;
- Patients with Hematocrit <28%;
- Patients with known structural heart disease;
- Patients with left bundle branch block;
- Patients with history of chronic left heart failure and left ventricular ejection fraction ≤30%;
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- Patients with abnormal renal function (serum creatinine > 1.8 mg/dL or >159 umol/L);
- Patients with known coagulopathy or bleeding tendency (platelet <100×109/L, or INR> 3);
- Patients who cannot receive antiplatelet or anticoagulant therapy;
- Patients who underwent cardiovascular or pulmonary open surgery within 7 days before peocedure;
- Patients with intracardiac thrombosis;
- Patients treated with extracorporeal membrane oxygenation;
- Patients known to be allergic to contrast agents;
- Patients with diseases that may cause difficulty in treatment or evaluation (such as malignant tumor, acute infectious disease, sepsis, general condition that cannot tolerate procedure, life expectancy less than one year, etc.);
- Females who are pregnant or in lactation;
- Patient is currently enrolled in another investigational study protocol;
- Other conditions not suitable for inclusion judged by the researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Thrombectomy Devices for the Treatment of Acute Pulmonary Embolism
To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.
- Being tested
- Stent-Retriever
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent-RetrieverDevice
all the participants in this group will be performed with Stent-Retriever
| Study group | Role | What they receive |
|---|---|---|
| Stent-Retriever arm | Experimental | Device: Stent-Retriever Receives: Device: Stent-Retriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in RV/LV ratio from baseline to 48 hours
Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.
Measured: 48 hours post procedure
Major Adverse Events from baseline to 48 hours
Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.
Measured: 48 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start3 Jan 2024
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Why it stopped: The clinical trial was terminated ahead of schedule due to strategic changes within the company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PE - Pulmonary EmbolismStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zenith Vascular SciTech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992168
- Sponsor's protocol ID
- SZZT-CP-202301
- Acronym
- SRAME
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Thrombectomy Devices for the Treatment of Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05992168
- Acronym / sponsor ID
- SRAME / SZZT-CP-202301
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical trial was terminated ahead of schedule due to strategic changes within the company.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Suzhou Zenith Vascular SciTech LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 15 Aug 2023 (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.
To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent-Retriever arm | Experimental | Device: Stent-RetrieverDevice: Stent-Retriever |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18≤ age ≤75, no gender limitation; 2.patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance; 3.RV/LV ratio ≥0.9; 4.Patients who agreed to participate in the study and voluntarily signed the informed consent.
Key exclusion criteria (17 listed)
- Patients with systolic blood pressure<90 mmHg and lasting for 15 minutes or requiring maintenance of systolic blood pressure ≥ 90 mmHg;
- Patients with known severe pulmonary hypertension;
- Patients with Hematocrit <28%;
- Patients with known structural heart disease;
- Patients with left bundle branch block;
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 |
|---|---|---|
| Stent-Retrieverall the participants in this group will be performed with Stent-Retriever | Device | Stent-Retriever arm |
Primary outcome
Reduction in RV/LV ratio from baseline to 48 hours
Time frame: 48 hours post procedure
Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.
Major Adverse Events from baseline to 48 hours
Time frame: 48 hours post procedure
Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.
Results and safety
The study was stopped early (reason given: The clinical trial was terminated ahead of schedule due to strategic changes within the company.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent-Retriever in people with PE - Pulmonary Embolism and PE - Pulmonary Thromboembolism, run by Suzhou Zenith Vascular SciTech Limited 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 1 inclusion and 17 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: stopped early, as of the sponsor's last update on 18 Sep 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?
The study was stopped early (reason given: The clinical trial was terminated ahead of schedule due to strategic changes within the company.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in RV/LV ratio from baseline to 48 hours (time frame: 48 hours post procedure). The study lists 2 primary outcomes in all. 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 18 Sep 2025.