A Clinical Trial to Evaluate the Efficacy and Safety of TwiFlow-System for Acute Pulmonary Embolism (TwiFlow)

An Exploratory Study to Evaluate the Safety and Efficacy of a Novel Transcatheter Pulmonary Thrombectomy System Which Named 'TwiFlow' for Acute Pulmonary Embolism

For a prospective, single-arm clinical study, this study plans to recruit patients with acute pulmonary intravascular embolization, use 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, for evaluating the efficacy and safety of this novel system in the treatment of patients with pulmonary intravascular embolization disease.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: TwiFlow-Thrombectomy Catheter System

Detailed Description

As a 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 Xiamen Cardiovascular Hospital, Xiamen University. A total of 3 subjects are planned to be enrolled. 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 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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 210046
      • Atrial shunt implant system

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. 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. Hematocrit < 28%;
4. Patients with a history of chronic pulmonary hypertension;
5. Patients with left bundle branch block;
6. A history of chronic left heart failure and left ventricular ejection fraction ≤30%;
7. Patients with abnormal renal function (serum creatinine > 1.8 mg/dL or >159 umol/L);
8. Patients with known coagulopathy or bleeding tendency (platelet <100×109/L, or INR> 3);
9. Patients who cannot receive antiplatelet or anticoagulant therapy;
10. Patients who underwent cardiovascular or pulmonary open surgery within 7 days before surgery;
11. Patients with intracardiac thrombosis;
12. Patients treated with extracorporeal membrane oxygenation;
13. Patients known to be allergic to contrast agents;
14. 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 one year, etc.);
15. Pregnant and lactating women;
16. Patients who are participating in clinical trials of other drugs or medical devices;
17. Other patients deemed unsuitable for the study by the investigator;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; The arm contains patients with acute pulmonary embolism who undergoing interventional therapy with transcatheter pulmonary embolectomy system which named 'TwiFlow-Thrombectomy Catheter System'	Device: TwiFlow-Thrombectomy Catheter System; 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'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
instrument performance evaluation	Whether the plug remover is delivered to the specified location or not, whether the thrombectomy stent was successfully deployed or not, whether the plug is retracted successfully or not, whether the thrombectomy device safely removed from the body or not. Whether the conveying system delivers to the specified location or not, whether the delivery system safely removed from the body or not.	intraoperative period
the success rate of surgery	Surgical success was defined as successful thrombectomy without MAE.	intraoperative period
postoperative immediate target lesion embolus removal efficiency	Thrombus clearance = (postoperative target vascular diameter - preoperative target vascular diameter)/preoperative target vascular diameter x100%. The thrombus clearance rate of target lesions can be divided into three grades: <50%, 50-90% and > 90% respectively, in which the thrombus clearance rate ≥50% is effective.	before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately
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	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 = postoperative arterial oxygen partial pressure - preoperative arterial oxygen partial pressure	before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately
death rates related to the equipment in 48 hours after surgery	death rates	48 hours after surgery
incident rate of bleeding in 48 hours after operation	incident rate of bleeding	48 hours 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	48 hours after surgery
postoperative pulmonary vascular injury incidence in 48 hours after surgery	Pulmonary vascular injury: Defined as perforation or injury of a major pulmonary artery branch requiring surgical open surgical intervention.	48 hours after surgery
the incidence of heart damage injury in 48 hours after surgery	Cardiac injury: Defined as heart injury requiring surgical open surgical intervention.	48 hours after surgery
all-cause death rate in 30 days after surgery	all-cause death	30 days after surgery
symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery	patients present with pulmonary embolism again	30 days after surgery

Collaborators and Investigators

• Sponsor: Morningside (Nantong) Medical Co.,Ltd
• Collaborators: Xiamen Cardiovascular Hospital, Xiamen University
• Investigators: Study Chair: Hui Zhuang, Dr., Xiamen Cardiovascular Hospital, Xiamen University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• FLASH study Interim Results.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: CHENXING-2022-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No