Peripheral Thrombotic Lesions
Conditions
Interventions
Case series:NA
Sponsors
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects who have provided written informed consent and voluntarily enrolled in this study must demonstrate the willingness and capability to comply with all data collection procedures. 2. Investigators shall enroll subjects based on the product's indications and contraindications and administer treatment in strict accordance with the product's Instructions for Use (IFU). 1) The Disposable Peripheral Vascular Thrombectomy Catheter is intended for use with a compatible thrombectomy system console to remove thrombi from the following sites: peripheral arteries of the upper and lower extremities with a diameter >=3.0 mm; peripheral veins of the upper extremities with a diameter >=3.0 mm; iliac, femoral, and lower extremity veins with a diameter >=3.0 mm; and blood vessels of arteriovenous fistulae with a diameter >=3.0 mm. When used with the compatible console's thrombolytic spray function, it enables the injection of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system. This catheter is indicated for peripheral vascular arteriovenous thrombotic stenotic or occlusive lesions, or when thrombus debulking is required prior to procedures such as Percutaneous Transluminal Angioplasty (PTA) or Stenting (PTAS) for thrombotic lesions. 2) Separately, the Peripheral Venous Thrombectomy Catheter is intended for use with the company's thrombectomy system console to remove thrombi from peripheral veins of the upper extremities with a diameter >=6.0 mm, as well as iliac, femoral, and lower extremity veins with a diameter >=6.0 mm. When used with the thrombolytic spray function of the company's console, it allows for the infusion of physician-specified fluids, including thrombolytic agents, into the peripheral venous vasculature.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications to endovascular interventional therapy. 2. Patients with uncorrected bleeding disorders who cannot receive thrombolytic agents. 3. Patients who cannot tolerate the use of contrast agents. 4. Patients with target vascular lesions that cannot be traversed with a guidewire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical Success Rate of the Thrombectomy Device; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Success Rate of the Thrombectomy Procedure;Perioperative Primary Patency Rate; | — |
Countries
China
Contacts
Public ContactWang Gang
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed