A Clinical Trial to Evaluate the Efficacy and Safety of TwiFlow-System for Acute Pulmonary Embolism
NCT05443919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2023-05-15
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
Interventions
- 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'.
Sponsors & Collaborators
-
Xiamen Cardiovascular Hospital, Xiamen University
collaborator OTHER -
Morningside (Nantong) Medical Co.,Ltd
lead OTHER
Principal Investigators
-
Hui Zhuang, Dr. · Xiamen Cardiovascular Hospital, Xiamen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2022-12-10
- Completion
- 2023-01-10
Countries
- China
Study Locations
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