search
Back to results

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

Primary Purpose

Pulmonary Embolism and Thrombosis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Balloon thrombectomy
Thromboaspiration system
Sponsored by
Instituto de Investigacion Sanitaria La Fe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism and Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital La FeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Balloon thrombectomy

Thromboaspiration system

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Full Information

First Posted
July 12, 2023
Last Updated
September 18, 2023
Sponsor
Instituto de Investigacion Sanitaria La Fe
Collaborators
Hospital Universitario Doctor Peset
search

1. Study Identification

Unique Protocol Identification Number
NCT06051032
Brief Title
Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy vs. Thromboaspiration.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigacion Sanitaria La Fe
Collaborators
Hospital Universitario Doctor Peset

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism and Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balloon thrombectomy
Arm Type
Experimental
Arm Description
Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo balloon thrombectomy.
Arm Title
Thromboaspiration system
Arm Type
Experimental
Arm Description
Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo the thromboaspiration system.
Intervention Type
Device
Intervention Name(s)
Balloon thrombectomy
Intervention Description
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
Intervention Name(s)
Thromboaspiration system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of PTE after thrombectomy of native and prosthetic AVFs.
Description
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)
Time Frame
The presence of PTE will be evaluated within 24 hours after treatment.
Title
PTE resolution rate 1 month after thrombectomy of native and prosthetic AVFs.
Description
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)
Time Frame
The resolution of PTE will be evaluated 1-month after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Martínez Rodrigo
Phone
+34 961244369
Email
martinez_jjo@gva.es
Facility Information:
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Marínez Rodrigo
Phone
+34961244369

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs