A Clinical Trial to Evaluate the Efficacy & Safety of TwiFlow-System for

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05443919
Study type	Interventional
Source	Morningside (Nantong) Medical Co.,Ltd
Contact
Status	Completed
Phase	N/A
Start date	September 1, 2022
Completion date	January 10, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05050617` - Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
Terminated	`NCT04558125` - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism	Phase 4
Not yet recruiting	`NCT06017271` - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Completed	`NCT03915925` - Short-term Clinical Deterioration After Acute Pulmonary Embolism
Completed	`NCT02502396` - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Recruiting	`NCT05171075` - A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE	Phase 3
Completed	`NCT04454554` - Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
Completed	`NCT03173066` - Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography	Phase 1
Terminated	`NCT03002467` - Impact Analysis of Prognostic Stratification for Pulmonary Embolism	N/A
Completed	`NCT02334007` - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery	Phase 1/Phase 2
Completed	`NCT02611115` - Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.	N/A
Completed	`NCT01975090` - The SENTRY Clinical Study	N/A
Not yet recruiting	`NCT01357941` - Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)	N/A
Completed	`NCT01326507` - Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism	N/A
Completed	`NCT02476526` - Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease	Phase 4
Completed	`NCT00720915` - D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months	N/A
Completed	`NCT00773448` - Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism	N/A
Completed	`NCT00780767` - Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism	Phase 2
Completed	`NCT00771303` - Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
Completed	`NCT00816920` - Natural History of Isolated Deep Vein Thrombosis of the Calf

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms