Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy Vs. Thromboaspiration.

Instituto de Investigacion Sanitaria La Fe

Status: Enrolling

Conditions: Pulmonary Embolism and Thrombosis

Treatments: Device: Balloon thrombectomy; Device: Thromboaspiration system

Study type: Interventional

Funder types: Other

Identifiers

NCT06051032

2022-803-1

Details and patient eligibility

About

The goal of this multicentric clinical trial is to compare the incidence of pulmonary thromboembolism (PTE), assessed through AngioCT, in the endovascular treatment of acute thrombosis in native and prosthetic arteriovenous fistulas (AVF). The main questions it aims to answer are:

• What is the difference in the incidence of pulmonary thromboembolism (PTE) assessed by AngioCT in endovascular treatment of acute thrombosis of native and prosthetic arteriovenous fistulas using balloon thrombectomy versus thromboaspiration systems?
• What is the primary patency rate of arteriovenous fistulas treated with balloon thrombectomy versus thromboaspiration systems?
• What is the clinical success rate in the treatment of arteriovenous fistulas using balloon thrombectomy compared to thromboaspiration systems?
• What are the costs associated with the different thrombectomy techniques in the treatment of arteriovenous fistulas?

Participants will be underwent to balloon thrombectomy versus thromboaspiration systems.

Researchers will compare the patients treated with balloon thrombectomy and thromboaspiration systems to see if the incidence of PE is comparable and to evaluate the primary and secondary patency rates of both thrombectomy techniques, the clinical technical success rate, and the costs associated with each technique.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute thrombosis (< 10 days) of native or prosthetic AVF.

Exclusion criteria

• Known pulmonary hypertension.
• Severe pulmonary disease.
• Low cardiopulmonary reserve.
• Recent creation of vascular access.
• Known right left shunt.
• Access infection.
• Allergy to iodinated contrast.
• Patients under 18 years old.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Balloon thrombectomy

Experimental group

Description:

Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo balloon thrombectomy.

Treatment:

Device: Balloon thrombectomy

Thromboaspiration system

Experimental group

Description:

Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo the thromboaspiration system.

Treatment:

Device: Thromboaspiration system