Skip to content

A Prospective, Multicenter, Single-Arm, Real-World Study on the Safety and Efficacy of the Disposable Peripheral Vascular Thrombectomy Catheter/Thrombectomy System Console for the Treatment of Thrombotic Lesions

A Prospective, Multicenter, Single-Arm, Real-World Study on the Safety and Efficacy of the Disposable Peripheral Vascular Thrombectomy Catheter/Thrombectomy System Console for the Treatment of Thrombotic Lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126118
Enrollment
Unknown
Registered
2026-06-03
Start date
2026-06-03
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Thrombotic Lesions

Interventions

Case series:None

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient signed the informed consent form, voluntarily participated in this study, and was willing and capable of cooperating with the data collection in this study. 2. The researchers selected the subjects based on the product indications and contraindications, and treated the subjects using the product in accordance with the product instructions: (1) The disposable peripheral vascular thrombus aspiration catheter was used in conjunction with a compatible thrombus aspiration control system for treating thrombus in the following areas: upper and lower extremity peripheral arteries with a diameter of >= 3.0 mm; upper extremity peripheral veins with a diameter of >= 3.0 mm; iliac-femoral and lower extremity veins with a diameter of >= 3.0 mm; arteriovenous fistula vessels with a diameter of >= 3.0 mm. When used together with the thrombus aspiration control system's thrombolysis spray function, it can inject the liquid specified by the physician (including thrombolytic drugs) into the peripheral vascular system. It is used for peripheral vascular arteriovenous thrombus stenosis or occlusive lesions, or for thrombus lesions in percutaneous transluminal angioplasty (PTA) or stent procedures that require pre-treatment for thrombus reduction. (2) The peripheral venous thrombus aspiration catheter was used together with the company's thrombus aspiration control instrument to remove thrombus from the following areas: upper extremity peripheral veins with a diameter of >= 6.0 mm; iliac-femoral and lower extremity veins with a diameter of >= 6.0 mm; when used together with the thrombus aspiration control instrument's thrombolysis spray function, the liquid specified by the physician (including thrombolytic agents) was infused into the peripheral venous vascular system.

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

MeasureTime frame
Technical Success Rate of the Thrombectony;

Secondary

MeasureTime frame
Cincal Success Rale of the Thrombectony;Perioperative Primary Patency Rate;

Countries

China

Contacts

Public ContactDai Xiangchen

Tianjin Medical University General Hospital

13302165917@163.com+86 133 0216 5917

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026