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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
China
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 Pulmonary Embolism

Eligibility Criteria

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

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;

Sites / Locations

  • Atrial shunt implant system

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
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.
the success rate of surgery
Surgical success was defined as successful thrombectomy without MAE.
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.
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 = postoperative arterial oxygen partial pressure - preoperative arterial oxygen partial pressure
death rates related to the equipment in 48 hours after surgery
death rates
incident rate of bleeding in 48 hours after operation
incident rate of bleeding
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
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.
the incidence of heart damage injury in 48 hours after surgery
Cardiac injury: Defined as heart injury requiring surgical open surgical intervention.
all-cause death rate in 30 days after surgery
all-cause death
symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery
patients present with pulmonary embolism again

Full Information

First Posted
June 23, 2022
Last Updated
May 12, 2023
Sponsor
Morningside (Nantong) Medical Co.,Ltd
Collaborators
Xiamen Cardiovascular Hospital, Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT05443919
Brief Title
A Clinical Trial to Evaluate the Efficacy and Safety of TwiFlow-System for Acute Pulmonary Embolism
Acronym
TwiFlow
Official Title
An Exploratory 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
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morningside (Nantong) Medical Co.,Ltd
Collaborators
Xiamen Cardiovascular Hospital, Xiamen University

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
13 (Actual)

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
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.
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
postoperative immediate target lesion embolus removal efficiency
Description
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.
Time Frame
before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately
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 = postoperative arterial oxygen partial pressure - preoperative arterial oxygen partial pressure
Time Frame
before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately
Title
death rates related to the equipment in 48 hours after surgery
Description
death rates
Time Frame
48 hours after surgery
Title
incident rate of bleeding in 48 hours after operation
Description
incident rate of bleeding
Time Frame
48 hours 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
postoperative pulmonary vascular injury incidence in 48 hours after surgery
Description
Pulmonary vascular injury: Defined as perforation or injury of a major pulmonary artery branch requiring surgical open surgical intervention.
Time Frame
48 hours after surgery
Title
the incidence of heart damage injury in 48 hours after surgery
Description
Cardiac injury: Defined as heart injury requiring surgical open surgical intervention.
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 present with pulmonary embolism again
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; 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; Hematocrit < 28%; Patients with a history of chronic pulmonary hypertension; 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 >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 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 one year, 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Zhuang, Dr.
Organizational Affiliation
Xiamen Cardiovascular Hospital, Xiamen University
Official's Role
Study Chair
Facility Information:
Facility Name
Atrial shunt implant system
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
210046
Country
China

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

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