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

Pulmonary Embolism and Thrombosis Clinical Trial

Official title:

Prospective Randomized Comparative Study on the Incidence of Pulmonary Emboembolism (PE) After Endovascular Treatment of Thrombosed Dialysis Arterio Venous Fistulas (AVF): Balloon Thrombectomy Versus Thromboaspiration Systems.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051032
• Other study ID #: 2022-803-1
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: José Martínez Rodrigo
• Phone: +34 961244369
• Email: martinez_jjo[@]gva.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Embolism and Thrombosis
• Pulmonary Embolism
• Pulmonary Embolism and Thrombosis
• Thrombosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe	Hospital Universitario Doctor Peset

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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