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

NCT05443919 | Completed

• 1 other identifier: CHENXING-2022-02
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• instrument performance evaluation

  intraoperative period

• the success rate of surgery

  intraoperative period

• postoperative immediate target lesion embolus removal efficiency

  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

  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

  before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately

Study Arms (1)

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'

Device: TwiFlow-Thrombectomy Catheter System

Interventions

TwiFlow-Thrombectomy Catheter System DEVICE

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'.

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Morningside (Nantong) Medical Co.,Ltd: lead
• Xiamen Cardiovascular Hospital, Xiamen University: collaborator

Study Sites (1)

Atrial shunt implant system

Nantong, Jiangsu, 210046, China

Location

Related Publications (7)

• 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.

  PMID: 33598362 BACKGROUND

• 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.

  PMID: 31147112 BACKGROUND

• 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.

  PMID: 28941516 BACKGROUND

• 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.

  PMID: 33454291 BACKGROUND

• 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.

  PMID: 33154209 BACKGROUND

• 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.

  PMID: 31375449 RESULT

• 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.

  PMID: 31072507 RESULT

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hui Zhuang, Dr.

  Xiamen Cardiovascular Hospital, Xiamen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 5, 2022
• Study Start: September 1, 2022
• Primary Completion: December 10, 2022
• Study Completion: January 10, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)