Clinical trial NCT05792397: TwiFlow Thrombectomy Catheter sYstem for Acute Pulmonary Embolism (Twi-TYPE 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Pulmonary Embolism
Lead sponsor: Morningside (Nantong) Medical Co.,Ltd
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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. Duration of pulmonary embolism symptoms ≤14 days
5. Systolic blood pressure ≥90mmHg
6. Patients who agreed to participate in the study and voluntarily signed the informed consent.

Exclusion Criteria:

1. Target vessel diameter \< 6.6mm;
2. Calcification, plaque or stenosis of target lesions;
3. Pulmonary arterial hypertension with peak pulmonary arterial pressure \>70mmHg;
4. Vasopressor is required after infusion to maintain pressure ≥90mmHg;
5. Hematocrit \< 28%;
6. Patients with left bundle branch block;
7. A history of chronic left heart failure and left ventricular ejection fraction≤30%;
8. Patients with abnormal renal function (serum creatinine \> 1.8 mg/dL or \>159umol/L);
9. Patients with known coagulopathy or bleeding tendency (platelet\<100×109/L, or INR\> 3);
10. Patients who cannot receive antiplatelet or anticoagulant therapy;
11. Patients who underwent cardiovascular or pulmonary open surgery within 7 days before surgery;
12. Patients with intracardiac thrombosis;
13. Patients treated with extracorporeal membrane oxygenation;
14. Patients known to be allergic to contrast agents;
15. 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.);
16. Pregnant and lactating women;
17. Patients who are participating in clinical trials of other drugs or medical devices;
18. Other patients deemed unsuitable for the study by the investigator;

Primary outcomes:
measure: Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery
timeFrame: before and 48 hours after surgery
measure: The incidence of major adverse events (MAE) within 48 hours after surgery
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: instrument performance evaluation
timeFrame: intraoperative period
measure: the success rate of surgery
timeFrame: intraoperative period
measure: pulmonary artery pressure changes before and after operation value
timeFrame: before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately
measure: values of arterial oxygen partial pressure changes before and after operation
timeFrame: before the pulmonary intravascular embolization removal procedure began and 14 days after surgery
measure: postoperative clinical deterioration rate in 48 hours after surgery
timeFrame: 48 hours after surgery]
measure: all-cause death rate in 30 days after surgery
timeFrame: 30 days after surgery
measure: symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Xiamen Cardiovascular Hospital, Xiamen University
name: Zhuang Hui, Dr.
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.