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| Name | Class |
|---|---|
| Hospital Universitario Doctor Peset | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon thrombectomy | Experimental | Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo balloon thrombectomy. |
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| Thromboaspiration system | Experimental | Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo the thromboaspiration system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Martínez Rodrigo | Contact | +34 961244369 | martinez_jjo@gva.es |
| Name | Affiliation | Role |
|---|---|---|
| José Martínez Rodrigo | Hospital Universitario La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38353936 | Derived | 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. |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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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.
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| 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. |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |