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

NCT06051032 | Recruiting DMC FDA Device

• 1 other identifier: 2022-803-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence of PTE after thrombectomy of native and prosthetic AVFs.

  The following parameters will be assessed: Dialysis flow (mL/min), Dialysis Recirculation (%), Dialysis BP (Normal; Elevated), Dialysis PV (Normal; Elevated), Dialysis dose (Kt), Adequate dialysis (Yes, Not), Doppler AVF (Patent; Residual stenosis; Retrombosis; Thrombosis), PET presence (Yes, Not), PET location (Multilobar; Lobar; Segmental; Subsegmental), Hemodynamic overload, Pulmonary artery caliber (mm), Ventricle diameter dx (mm), RV/LV ratio (%), PET effect (Symptomatic; Asymptomatic)

  The presence of PTE will be evaluated within 24 hours after treatment.

• PTE resolution rate 1 month after thrombectomy of native and prosthetic AVFs.

  The following parameters will be assessed: Dialysis flow (mL/min), Dialysis Recirculation (%), Dialysis BP (Normal; Elevated), Dialysis PV (Normal; Elevated), Dialysis dose (Kt), Adequate dialysis (Yes, Not), Doppler AVF (Patent; Residual stenosis; Retrombosis; Thrombosis), PET resolution (Yes, Not), Hemodynamic overload, Pulmonary artery caliber (mm), Ventricle diameter dx (mm), RV/LV ratio (%), PET effect (Symptomatic; Asymptomatic)

  The resolution of PTE will be evaluated 1-month after the treatment

Study Arms (2)

Balloon thrombectomy

EXPERIMENTAL

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

Device: Balloon thrombectomy

Thromboaspiration system

EXPERIMENTAL

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

Device: Thromboaspiration system

Interventions

Balloon thrombectomy 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.

Balloon thrombectomy

Thromboaspiration system 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.

Thromboaspiration system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead
• Hospital Universitario Doctor Peset: collaborator

Study Sites (1)

Hospital La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 38353936 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• José Martínez Rodrigo

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Martínez Rodrigo

CONTACT

+34 961244369; martinez_jjo@gva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients diagnosed with arteriovenous fistula (AVF) thrombosis and eligible for endovascular treatment, based on predefined inclusion and exclusion criteria, will be enrolled in this study. They will be randomly assigned to receive either balloon thrombectomy or thromboaspiration systems.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: September 22, 2023
• Study Start: July 21, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

ES (1)