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

NCT ID: NCT06051032

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-21
• Study Completion Date: 2025-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Balloon thrombectomy

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

Group Type: EXPERIMENTAL

Balloon thrombectomy

Intervention Type: DEVICE

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.

Thromboaspiration system

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

Group Type: EXPERIMENTAL

Thromboaspiration system

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Doctor Peset

OTHER

Sponsor Role: collaborator

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Martínez Rodrigo

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Fe

Locations

Hospital La Fe

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

José Martínez Rodrigo

Role: CONTACT

martinez_jjo@gva.es

+34 961244369

Facility Contacts

José Marínez Rodrigo

Role: primary

+34961244369

References

Fonseca AV, Toledo Barros MG, Baptista-Silva JC, Amorim JE, Vasconcelos V. Interventions for thrombosed haemodialysis arteriovenous fistulas and grafts. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD013293. doi: 10.1002/14651858.CD013293.pub2.

Reference Type: DERIVED

PMID: 38353936 (View on PubMed)

Other Identifiers

2022-803-1

Identifier Type: -

Identifier Source: org_study_id