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

NCT06051032 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-28

No results posted yet for this study

Summary

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.

Conditions

  • Pulmonary Embolism and Thrombosis

Interventions

DEVICE

Balloon thrombectomy

A specialized catheter with an inflatable balloon at the tip is inserted over a guidewire, previously inserted through the sheath, and advanced to the location of the clot within the blood vessel. The catheter is positioned precisely using fluoroscopic guidance or other imaging modalities. Once positioned, the balloon is inflated, creating pressure against the clot and effectively removing or dislodging it from the vessel walls.

DEVICE

Thromboaspiration system

The thromboaspiration catheter is carefully guided to the site of the clot within the blood vessel. Once positioned, the suction mechanism is activated, creating a vacuum effect. The catheter gently aspirates or suctions the clot, gradually removing it from the vessel walls. The procedure is performed under fluoroscopic guidance or other imaging modalities to ensure accurate placement of the catheter and successful clot aspiration.

Sponsors & Collaborators

  • Hospital Universitario Doctor Peset

    collaborator OTHER

  • Instituto de Investigacion Sanitaria La Fe

    lead OTHER

Principal Investigators

  • José Martínez Rodrigo · Hospital Universitario La Fe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051032 on ClinicalTrials.gov