Acute Pulmonary EmbolismTwi-TYPENCT05792397
TwiFlow Thrombectomy Catheter sYstem for Acute Pulmonary Embolism (Twi-TYPE Study)
A study testing TwiFlow-Thrombectomy Catheter System in people with Acute Pulmonary Embolism, run by Morningside (Nantong) Medical Co.,Ltd.
Trial summary
As a multicenter prospective single-arm clinical study, the investigators plan to recruit patients with acute pulmonary intravascular embolization from nationwide multi-center hospital organizations in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- TwiFlow-Thrombectomy Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 May 2026
- 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
- 18≤ age ≤75, no gender limitation;
- patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance;
- RV/LV ratio ≥0.9;
- Duration of pulmonary embolism symptoms ≤14 days
- Systolic blood pressure ≥90mmHg
- Patients who agreed to participate in the study and voluntarily signed the informed consent.
Who cannot join
- Target vessel diameter < 6.6mm;
- Calcification, plaque or stenosis of target lesions;
- Pulmonary arterial hypertension with peak pulmonary arterial pressure >70mmHg;
- Vasopressor is required after infusion to maintain pressure ≥90mmHg;
- Hematocrit < 28%;
- Patients with left bundle branch block;
Show all 18Show fewer
- A history of chronic left heart failure and left ventricular ejection fraction≤30%;
- Patients with abnormal renal function (serum creatinine > 1.8 mg/dL or >159umol/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 surgery;
- 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 and evaluation (such as malignant tumor, acute infectious disease, sepsis, general condition that cannot tolerate surgery, life expectancy less than 3 months, etc.);
- Pregnant and lactating women;
- Patients who are participating in clinical trials of other drugs or medical devices;
- Other patients deemed unsuitable for the study by the investigator;
Trial locations and contacts
No sites are listed yet.
Zhuang Hui, Dr. contact
About this study
Official title: A Multicenter Prospective Single-arm Study to Evaluate the Safety and Efficacy of a Novel Transcatheter Pulmonary Thrombectomy System Which Named 'TwiFlow' for Acute Pulmonary Embolism
As a multicenter prospective single-arm clinical study, the investigators plan to recruit patients with acute pulmonary intravascular embolization from nationwide multi-center hospital organizations in China. The investigators use the production of transcatheter pulmonary artery bolt system which named 'TwiFlow Thrombectomy Catheter System' developed by the MorningSide (NanTong) medical device Co., LTD. on pulmonary artery interventional therapy to evaluating the efficacy and safety of this novel system in the treatment of patients with pulmonary intravascular embolization disease.
Read the detailed description
As a multicenter prospective single-arm clinical study, the investigators plan to evaluate the new production's efficacy and safety which named 'TwiFlow-Thrombectomy Catheter System'. This study will be carried out in nationwide multi-center hospital organizations in China. According to the statistical principle, the sample size of this study was estimated, and the final number of selected cases was 127. After screening, all subjects will be treated with transcatheter pulmonary artery thrombectomy system, and clinical follow-up will be conducted at 48 hours, 14 days and 30 days after surgery. Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery and the incidence of major adverse events (MAE) within 48 hours after surgery were used as primary endpoints. In instrument performance evaluation, the success rate of surgery, postoperative immediate target lesion embolus removal efficiency, pulmonary artery pressure changes before and after operation value, values of arterial oxygen partial pressure changes before and 14 days after operation, death rates related to the equipment in 48 hours after surgery, incident rate of bleeding in 48 hours after operation, postoperative clinical deterioration rate in 48 hours after surgery, postoperative pulmonary vascular injury incidence in 48 hours after surgery, the incidence of heart damage injury in 48 hours after surgery, all-cause death rate in 30 days after surgery, and symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery were secondary endpoints.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- TwiFlow-Thrombectomy Catheter System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TwiFlow-Thrombectomy Catheter SystemDevice
Patients with acute pulmonary embolism and meeting the conditions of this clinical trial will accept the pulmonary embolism removal operation by the novel device named 'TwiFlow-Thrombectomy Catheter System'
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The arm contains patients with acute pulmonary embolism who undergoing interventional therapy with transcatheter pulmonary embolectomy system which named 'TwiFlow-Thrombectomy Catheter System' Receives: Device: TwiFlow-Thrombectomy Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery
Right Ventricular (RV) and Left Ventricular (LV) were recorded during the screening period and 48 hours after surgery by echocardiography or pulmonary artery CT (CTPA), and RV/LV and RV/LV reduction were calculated. The target RV/ LV reduction from baseline to 48 hours after surgery was at least 0.2.
Measured: before and 48 hours after surgery
The incidence of major adverse events (MAE) within 48 hours after surgery
The incidence of major adverse events (MAE) during and 48 hours after surgery was observed and recorded, and the incidence of MAE was calculated (referring to the definition of MAE). The target incidence of MAE 48 hours after surgery was less than 25%.
MAE events defined as those occurring within 48 hours of treatment include device-related death, massive bleeding, pulmonary vascular injury, and cardiac injury.
Haemorrhage: Disabling or life-threatening bleeding, or severe haemodynamic injury.
Pulmonary vascular injury: Defined as perforation or injury of a major pulmonary artery branch requiring surgical open surgical intervention.
Cardiac injury: Defined as heart injury requiring surgical open surgical intervention.
Measured: 48 hours after surgery
Secondary outcomes (7)
instrument performance evaluation
researchers try to evaluate the twi-system instrument' performance during the operation, so investigators will review whether the device system successfully performed the following steps: 1.Pulmonary thrombectomy system transport to the thromboembolic site (yes or not), 2.The thrombectomy stent was successfully deployed (yes or not), 3.the clot-plug is retracted successfully (yes or not), 4. the thrombectomy device safely removed from the body (yes or not), 5. Thrombus suction catheter delivers to the specified thromboembolic location (yes or not), 6.the thrombus suction catheter delivery system safely removed from the body (yes or not). The study predefine the answer"yes" to 1 point and "no" to 0 point, then investigators will calculate the total scores according above 6 steps and evaluate the twi-system instrument' performance during the operation.
Measured: intraoperative period
the success rate of surgery
Surgical success was defined as successful thrombectomy without MAE.
Measured: intraoperative period
pulmonary artery pressure changes before and after operation value
Changes in pulmonary artery pressure before and after operation = postoperative pulmonary artery pressure - preoperative pulmonary artery pressure
Measured: before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately
values of arterial oxygen partial pressure changes before and after operation
Preoperative and postoperative arterial oxygen partial pressure = 14 days postoperative arterial oxygen partial pressure - preoperative arterial oxygen partial pressure
Measured: before the pulmonary intravascular embolization removal procedure began and 14 days after surgery
postoperative clinical deterioration rate in 48 hours after surgery
Clinical deterioration include instrumentation related events such as unplanned endotracheal intubation, mechanical ventilation, arterial hypotension (>1 hour) or shock, cardiopulmonary resuscitation, significant deterioration of oxygenation, and emergency surgical embolectomy.
Measured: 48 hours after surgery]
all-cause death rate in 30 days after surgery
all-cause death
Measured: 30 days after surgery
symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery
patients occur pulmonary embolism again and represent related clinical symptoms
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morningside (Nantong) Medical Co.,Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhuang Hui, Dr., Study chair, Xiamen Cardiovascular Hospital, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792397
- Sponsor's protocol ID
- CHENXING-2022-05
- Acronym
- Twi-TYPE
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore K, Kunin J, Alnijoumi M, Nagpal P, Bhat AP. Current Endovascular Treatment Options in Acute Pulmonary Embolism. J Clin Imaging Sci. 2021 Jan 25;11:5. doi: 10.25259/JCIS_229_2020. eCollection 2021.
PubMed 33598362Villalba L, Nguyen T, Feitosa RL Jr, Gunanayagam P, Anning N, Dwight K. Single-session catheter-directed lysis using adjunctive power-pulse spray with AngioJet for the treatment of acute massive and submassive pulmonary embolism. J Vasc Surg. 2019 Dec;70(6):1920-1926. doi: 10.1016/j.jvs.2019.03.038. Epub 2019 May 27.
PubMed 31147112Al-Hakim R, Bhatt A, Benenati JF. Continuous Aspiration Mechanical Thrombectomy for the Management of Submassive Pulmonary Embolism: A Single-Center Experience. J Vasc Interv Radiol. 2017 Oct;28(10):1348-1352. doi: 10.1016/j.jvir.2017.06.025.
PubMed 28941516Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Dohad S, Amoroso NE, Dexter DJ, Loh CT, Leung DA, Bieneman BK, Perkowski PE, Chuang ML, Benenati JF; EXTRACT-PE Investigators. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13.
PubMed 33454291Wible BC, Buckley JR, Cho KH, Bunte MC, Saucier NA, Borsa JJ. Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device. J Vasc Interv Radiol. 2019 Sep;30(9):1370-1375. doi: 10.1016/j.jvir.2019.05.024. Epub 2019 Jul 30.
PubMed 31375449Yasin JT, Davis R, Saemi A, Regunath H, Krvavac A, Saboo SS, Bhat AP. Technical efficiency, short-term clinical results and safety of a large-bore aspiration catheter in acute pulmonary embolism - A retrospective case study. Lung India. 2020 Nov-Dec;37(6):485-490. doi: 10.4103/lungindia.lungindia_115_20.
PubMed 33154209Tu T, Toma C, Tapson VF, Adams C, Jaber WA, Silver M, Khandhar S, Amin R, Weinberg M, Engelhardt T, Hunter M, Holmes D, Hoots G, Hamdalla H, Maholic RL, Lilly SM, Ouriel K, Rosenfield K; FLARE Investigators. A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study. JACC Cardiovasc Interv. 2019 May 13;12(9):859-869. doi: 10.1016/j.jcin.2018.12.022.
PubMed 31072507
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Single-arm Study to Evaluate the Safety and Efficacy of a Novel Transcatheter Pulmonary Thrombectomy System Which Named 'TwiFlow' for Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05792397
- Acronym / sponsor ID
- Twi-TYPE / CHENXING-2022-05
- Conditions
- Acute Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Morningside (Nantong) Medical Co.,LtdUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 31 Mar 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.
As a multicenter prospective single-arm clinical study, the investigators plan to recruit patients with acute pulmonary intravascular embolization from nationwide multi-center hospital organizations in China. The investigators use the production of transcatheter pulmonary artery bolt system which named 'TwiFlow Thrombectomy Catheter System' developed by the MorningSide (NanTong) medical device Co., LTD. on pulmonary artery interventional therapy to evaluating the efficacy and safety of this novel system in the treatment of patients with pulmonary intravascular embolization disease.
Detailed description
As a multicenter prospective single-arm clinical study, the investigators plan to evaluate the new production's efficacy and safety which named 'TwiFlow-Thrombectomy Catheter System'. This study will be carried out in nationwide multi-center hospital organizations in China. According to the statistical principle, the sample size of this study was estimated, and the final number of selected cases was 127. After screening, all subjects will be treated with transcatheter pulmonary artery thrombectomy system, and clinical follow-up will be conducted at 48 hours, 14 days and 30 days after surgery. Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery and the incidence of major adverse events (MAE) within 48 hours after surgery were used as primary endpoints. In instrument performance evaluation, the success rate of surgery, postoperative immediate target lesion embolus removal efficiency, pulmonary artery pressure changes before and after operation value, values of arterial oxygen partial pressure changes before and 14 days after operation, death rates related to the equipment in 48 hours after surgery, incident rate of bleeding in 48 hours after operation, postoperative clinical deterioration rate in 48 hours after surgery, postoperative pulmonary vascular injury incidence in 48 hours after surgery, the incidence of heart damage injury in 48 hours after surgery, all-cause death rate in 30 days after surgery, and symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery were secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: TwiFlow-Thrombectomy Catheter SystemThe arm contains patients with acute pulmonary embolism who undergoing interventional therapy with transcatheter pulmonary embolectomy system which named 'TwiFlow-Thrombectomy Catheter System' |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18≤ age ≤75, no gender limitation;
- patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance;
- RV/LV ratio ≥0.9;
- Duration of pulmonary embolism symptoms ≤14 days
- Systolic blood pressure ≥90mmHg
Key exclusion criteria (18 listed)
- Target vessel diameter < 6.6mm;
- Calcification, plaque or stenosis of target lesions;
- Pulmonary arterial hypertension with peak pulmonary arterial pressure >70mmHg;
- Vasopressor is required after infusion to maintain pressure ≥90mmHg;
- Hematocrit < 28%;
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 |
|---|---|---|
| TwiFlow-Thrombectomy Catheter SystemPatients with acute pulmonary embolism and meeting the conditions of this clinical trial will accept the pulmonary embolism removal operation by the novel device named 'TwiFlow-Thrombectomy Catheter System' | Device | treatment group |
Primary outcome
Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery
Time frame: before and 48 hours after surgery
Right Ventricular (RV) and Left Ventricular (LV) were recorded during the screening period and 48 hours after surgery by echocardiography or pulmonary artery CT (CTPA), and RV/LV and RV/LV reduction were calculated. The target RV/ LV reduction from baseline to 48 hours after surgery was at least 0.2.
The incidence of major adverse events (MAE) within 48 hours after surgery
Time frame: 48 hours after surgery
The incidence of major adverse events (MAE) during and 48 hours after surgery was observed and recorded, and the incidence of MAE was calculated (referring to the definition of MAE). The target incidence of MAE 48 hours after surgery was less than 25%. MAE events defined as those occurring within 48 hours of treatment include device-related death, massive bleeding, pulmonary vascular injury, and cardiac injury. Haemorrhage: Disabling or life-threatening bleeding, or severe haemodynamic injury. Pulmonary vascular injury: Defined as perforation or injury of a major pulmonary artery branch requiring surgical open surgical intervention. Cardiac injury: Defined as heart injury requiring surgical open surgical intervention.
7 secondary outcomes
instrument performance evaluation
Time frame: intraoperative period
the success rate of surgery
Time frame: intraoperative period
pulmonary artery pressure changes before and after operation value
Time frame: before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately
values of arterial oxygen partial pressure changes before and after operation
Time frame: before the pulmonary intravascular embolization removal procedure began and 14 days after surgery
postoperative clinical deterioration rate in 48 hours after surgery
Time frame: 48 hours after surgery]
all-cause death rate in 30 days after surgery
Time frame: 30 days after surgery
symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Results publication: PubMed 33598362Moore K, Kunin J, Alnijoumi M, Nagpal P, Bhat AP. Current Endovascular Treatment Options in Acute Pulmonary Embolism. J Clin Imaging Sci. 2021 Jan 25;11:5. doi: 10.25259/JCIS_229_2020. eCollection 2021.
- Results publication: PubMed 31147112Villalba L, Nguyen T, Feitosa RL Jr, Gunanayagam P, Anning N, Dwight K. Single-session catheter-directed lysis using adjunctive power-pulse spray with AngioJet for the treatment of acute massive and submassive pulmonary embolism. J Vasc Surg. 2019 Dec;70(6):1920-1926. doi: 10.1016/j.jvs.2019.03.038. Epub 2019 May 27.
- Results publication: PubMed 28941516Al-Hakim R, Bhatt A, Benenati JF. Continuous Aspiration Mechanical Thrombectomy for the Management of Submassive Pulmonary Embolism: A Single-Center Experience. J Vasc Interv Radiol. 2017 Oct;28(10):1348-1352. doi: 10.1016/j.jvir.2017.06.025.
- Results publication: PubMed 33454291Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Dohad S, Amoroso NE, Dexter DJ, Loh CT, Leung DA, Bieneman BK, Perkowski PE, Chuang ML, Benenati JF; EXTRACT-PE Investigators. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13.
- Results publication: PubMed 31375449Wible BC, Buckley JR, Cho KH, Bunte MC, Saucier NA, Borsa JJ. Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device. J Vasc Interv Radiol. 2019 Sep;30(9):1370-1375. doi: 10.1016/j.jvir.2019.05.024. Epub 2019 Jul 30.
- Results publication: PubMed 33154209Yasin JT, Davis R, Saemi A, Regunath H, Krvavac A, Saboo SS, Bhat AP. Technical efficiency, short-term clinical results and safety of a large-bore aspiration catheter in acute pulmonary embolism - A retrospective case study. Lung India. 2020 Nov-Dec;37(6):485-490. doi: 10.4103/lungindia.lungindia_115_20.
- Results publication: PubMed 31072507Tu T, Toma C, Tapson VF, Adams C, Jaber WA, Silver M, Khandhar S, Amin R, Weinberg M, Engelhardt T, Hunter M, Holmes D, Hoots G, Hamdalla H, Maholic RL, Lilly SM, Ouriel K, Rosenfield K; FLARE Investigators. A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study. JACC Cardiovasc Interv. 2019 May 13;12(9):859-869. doi: 10.1016/j.jcin.2018.12.022.
- Individual participant dataSharing planned: No
Related trials for Acute Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Not yet recruitingPhase 3
Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features
Pulmonary Embolism
Not yet recruiting
Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
Acute Pulmonary Embolism
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
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.
Zhuang Hui, Dr. contact
Zhuang Hui, Dr. study chair
Xiamen Cardiovascular Hospital, Xiamen University
Questions about this trial
What is this clinical trial studying?
A study testing TwiFlow-Thrombectomy Catheter System in people with Acute Pulmonary Embolism, run by Morningside (Nantong) Medical Co.,Ltd.
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 6 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ni Linyan, Manager (+8613661929821, lyni@siriusmed.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery (time frame: before and 48 hours after surgery). 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?
On the ClinicalTrials.gov record for NCT05792397, which also lists 7 linked publications.
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 31 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.