Pulmonary Embolism and ThrombosisNCT06051032
Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy Vs. Thromboaspiration.
A study testing Balloon thrombectomy and Thromboaspiration system in people with Pulmonary Embolism and Thrombosis, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism and Thrombosis
- What is being tested?
- Balloon thrombectomy and Thromboaspiration system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jul 2023to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute thrombosis (< 10 days) of native or prosthetic AVF.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital La Fe
Valencia, Valencia, 46026
José Marínez Rodrigo, +34961244369
About this study
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.
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?
Read more
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
- Being tested
- Balloon thrombectomy, Thromboaspiration system
- Medical subject headings
- Pulmonary Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon thrombectomyDevice
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 systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Balloon thrombectomy | Experimental | Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo balloon thrombectomy. Receives: Device: Balloon thrombectomy |
| Thromboaspiration system | Experimental | Patients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo the thromboaspiration system. Receives: Device: Thromboaspiration system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: The resolution of PTE will be evaluated 1-month after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start21 Jul 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism and ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Doctor Peset
- Responsible party
- Sponsor
- Investigators
- José Martínez Rodrigo, Principal investigator, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051032
- Sponsor's protocol ID
- 2022-803-1
- Status last verified
- Jan 2025
- First submitted
- 12 Jul 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 38353936
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06051032
- Acronym / sponsor ID
- 2022-803-1
- Conditions
- Pulmonary Embolism and Thrombosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- Hospital Universitario Doctor Peset
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Balloon thrombectomy | Experimental | Device: Balloon thrombectomyPatients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo balloon thrombectomy. |
| Thromboaspiration system | Experimental | Device: Thromboaspiration systemPatients diagnosed with arteriovenous fistula (AVF) thrombosis and deemed eligible for endovascular treatment will undergo the thromboaspiration system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute thrombosis (< 10 days) of native or prosthetic AVF.
Key exclusion criteria (8 listed)
- Known pulmonary hypertension.
- Severe pulmonary disease.
- Low cardiopulmonary reserve.
- Recent creation of vascular access.
- Known right left shunt.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon thrombectomyA 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. | Device | Balloon thrombectomy |
| Thromboaspiration systemThe 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. | Device | Thromboaspiration system |
Primary outcome
Incidence of PTE after thrombectomy of native and prosthetic AVFs.
Time frame: 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.
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Derived from this study: PubMed 38353936Fonseca 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José Martínez Rodrigo principal investigator
Hospital Universitario La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon thrombectomy and Thromboaspiration system in people with Pulmonary Embolism and Thrombosis, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Martínez Rodrigo (+34 961244369, martinez_jjo@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PTE after thrombectomy of native and prosthetic AVFs. (time frame: The presence of PTE will be evaluated within 24 hours after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.