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TwiFlow Thrombectomy Catheter sYstem for Acute Pulmonary Embolism (Twi-TYPE Study) (Twi-TYPE)

Primary Purpose

Acute Pulmonary Embolism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TwiFlow-Thrombectomy Catheter System
Sponsored by
Morningside (Nantong) Medical Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pulmonary Embolism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment group

    Arm Description

    The arm contains patients with acute pulmonary embolism who undergoing interventional therapy with transcatheter pulmonary embolectomy system which named 'TwiFlow-Thrombectomy Catheter System'

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    the success rate of surgery
    Surgical success was defined as successful thrombectomy without MAE.
    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
    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
    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.
    all-cause death rate in 30 days after surgery
    all-cause death
    symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery
    patients occur pulmonary embolism again and represent related clinical symptoms

    Full Information

    First Posted
    March 5, 2023
    Last Updated
    March 18, 2023
    Sponsor
    Morningside (Nantong) Medical Co.,Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05792397
    Brief Title
    TwiFlow Thrombectomy Catheter sYstem for Acute Pulmonary Embolism (Twi-TYPE Study)
    Acronym
    Twi-TYPE
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Morningside (Nantong) Medical Co.,Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pulmonary Embolism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    127 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Experimental
    Arm Description
    The arm contains patients with acute pulmonary embolism who undergoing interventional therapy with transcatheter pulmonary embolectomy system which named 'TwiFlow-Thrombectomy Catheter System'
    Intervention Type
    Device
    Intervention Name(s)
    TwiFlow-Thrombectomy Catheter System
    Intervention Description
    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'
    Primary Outcome Measure Information:
    Title
    Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery
    Description
    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.
    Time Frame
    before and 48 hours after surgery
    Title
    The incidence of major adverse events (MAE) within 48 hours after surgery
    Description
    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.
    Time Frame
    48 hours after surgery
    Secondary Outcome Measure Information:
    Title
    instrument performance evaluation
    Description
    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.
    Time Frame
    intraoperative period
    Title
    the success rate of surgery
    Description
    Surgical success was defined as successful thrombectomy without MAE.
    Time Frame
    intraoperative period
    Title
    pulmonary artery pressure changes before and after operation value
    Description
    Changes in pulmonary artery pressure before and after operation = postoperative pulmonary artery pressure - preoperative pulmonary artery pressure
    Time Frame
    before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately
    Title
    values of arterial oxygen partial pressure changes before and after operation
    Description
    Preoperative and postoperative arterial oxygen partial pressure = 14 days postoperative arterial oxygen partial pressure - preoperative arterial oxygen partial pressure
    Time Frame
    before the pulmonary intravascular embolization removal procedure began and 14 days after surgery
    Title
    postoperative clinical deterioration rate in 48 hours after surgery
    Description
    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.
    Time Frame
    48 hours after surgery]
    Title
    all-cause death rate in 30 days after surgery
    Description
    all-cause death
    Time Frame
    30 days after surgery
    Title
    symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery
    Description
    patients occur pulmonary embolism again and represent related clinical symptoms
    Time Frame
    30 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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; 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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ni Linyan, Manager
    Phone
    +8613661929821
    Email
    lyni@siriusmed.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhuang Hui, Dr.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhuang Hui, Dr.
    Organizational Affiliation
    Xiamen Cardiovascular Hospital, Xiamen University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33598362
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    31147112
    Citation
    Villalba 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 Reference
    result
    PubMed Identifier
    28941516
    Citation
    Al-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 Reference
    result
    PubMed Identifier
    33454291
    Citation
    Sista 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 Reference
    result
    PubMed Identifier
    31375449
    Citation
    Wible 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 Reference
    result
    PubMed Identifier
    33154209
    Citation
    Yasin 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 Reference
    result
    PubMed Identifier
    31072507
    Citation
    Tu 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.
    Results Reference
    result
    Links:
    URL
    https://www.inarimedical.com/int/flash/
    Description
    FLASH study Interim Results.

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    TwiFlow Thrombectomy Catheter sYstem for Acute Pulmonary Embolism (Twi-TYPE Study)

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