Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy Vs. Thromboaspiration.
- Conditions
- Pulmonary Embolism and Thrombosis
- Interventions
- Device: Balloon thrombectomyDevice: Thromboaspiration system
- Registration Number
- NCT06051032
- Lead Sponsor
- Instituto de Investigacion Sanitaria La Fe
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Patients with acute thrombosis (< 10 days) of native or prosthetic AVF.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Balloon thrombectomy Balloon thrombectomy Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo balloon thrombectomy. Thromboaspiration system Thromboaspiration system Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo the thromboaspiration system.
- Primary Outcome Measures
Name Time Method Incidence of PTE after thrombectomy of native and prosthetic AVFs. The presence of PTE will be evaluated within 24 hours after treatment. 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)
PTE resolution rate 1 month after thrombectomy of native and prosthetic AVFs. The resolution of PTE will be evaluated 1-month after the treatment 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain