Abdominal AneurysmPRIZENCT06975215
Pre-emptive Coil Embolization in Endovascular Aortic Repair
A study testing Concomitant embolization and EVAR in people with Abdominal Aneurysm and Endovascular Aortic Repair, run by Uppsala University.
Trial summary
Abdominal aortic aneurysms are often treated with a minimally invasive procedure called endovascular aortic repair (EVAR). While EVAR is widely used, it can sometimes lead to complications over time, and some patients may require further procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aneurysm, Endovascular Aortic Repair, Endoleak
- What is being tested?
- Concomitant embolization and EVAR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2033
- 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
- Abdominal aortic aneurysms with a maximum aortic diameter above the threshold for repair level.
- High-risk criteria for type 2 endoleaks
Who cannot join
- Does not fulfill instructions for use for standard EVAR
- Contraindication for EVAR
- Life expectancy less than 2 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pre-emptive Coil Embolization in Endovascular Aortic Repair: The PRIZE Study
Abdominal aortic aneurysms are often treated with a minimally invasive procedure called endovascular aortic repair (EVAR). While EVAR is widely used, it can sometimes lead to complications over time, and some patients may require further procedures. One of the main issues is endoleak, which occurs when blood continues to flow into the aneurysm sac after treatment. This often happens because small nearby blood vessels, or other sources, continue to supply blood to the aneurysm.
A potentialy strategy to reduce the risk of endoleak is pre-emptive embolization-a technique used during EVAR to block these sources of persistent blood flow. This can include embolization of side branches, the aneurysm sac, or other contributing vessels. Early findings suggest that pre-emptive embolization may lower the risk of endoleaks, but it is still uncertain whether it improves long-term outcomes.
Read more
The PRIZE study (Randomized Controlled Trial on Pre-emptive Coil Embolization in Endovascular Aortic Repair) is designed to answer this question. In this research, patients are randomly assigned to one of two groups: one group will receive EVAR with pre-emptive embolization, and the other will receive EVAR without it.
Two main outcomes will be assessed. The first is aneurysm sac regression at two years, meaning a reduction in the size of the aneurysm sac after treatment. This is important because sac shrinkage after EVAR has been linked to lower overall mortality, even though the exact reasons for this are not yet fully understood. The second main outcome is the rate of aortic-related events over five years, as ensuring the long-term durability of treatment is a key goal of this study. Secondary outcomes, including quality of life, patient satisfaction, and cost-effectiveness will also be evaluated.
Currently, there is no clear agreement on whether pre-emptive embolization should be routinely used during EVAR. In a recent international survey, 76% of aortic specialists agreed that more evidence is needed. The PRIZE study aims to provide that evidence. If pre-emptive embolization proves effective, it could become a standard addition to EVAR, helping to improve both the immediate success and long-term durability of treatment. If not, the study will help avoid unnecessary procedures, ensuring patients receive only treatments that offer real benefits.
- Conditions
- Abdominal Aneurysm, Endovascular Aortic Repair, Endoleak
- Being tested
- Concomitant embolization, EVAR
- Medical subject headings
- Aortic Aneurysm, Abdominal, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concomitant embolizationDevice
This will include EVAR, following the standard pathway of care, associated with embolization. The decision to perform side-branch embolization or aneurysm sac embolization will be left to each participating centre/physician.
EVARProcedure or surgery
Endovascular aortic aneurysm repair
| Study group | Role | What they receive |
|---|---|---|
| EVAR | Active comparator | EVAR, as per standard of care Receives: Procedure: EVAR |
| EVAR + embolization | Experimental | EVAR, as per standard of care, associated with concomitant embolization Receives: Device: Concomitant embolization; Procedure: EVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm sac regression at 2 years
Changes in the maximum aneurysm sac volume, which will be to assessed by an independent core lab.
Measured: 24 months
Rate of aortic events at 5 years
The number of study participants with aortic events, including:
- Aortic-related reinterventions
- Development of type I/III, with or without reintervention
- Development of T2EL with sac expansion >10mm with or without reintervention
- Graft infection
- Aneurysm rupture
- Aortic-related death
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal AneurysmStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975215
- Sponsor's protocol ID
- PRIZE
- Acronym
- PRIZE
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Coil Embolization in Endovascular Aortic Repair: The PRIZE Study
- ClinicalTrials.gov ID
- NCT06975215
- Acronym / sponsor ID
- PRIZE / PRIZE
- Conditions
- Abdominal Aneurysm, Endovascular Aortic Repair, Endoleak
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2033 (estimated)
- First posted
- 16 May 2025 (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.
Abdominal aortic aneurysms are often treated with a minimally invasive procedure called endovascular aortic repair (EVAR). While EVAR is widely used, it can sometimes lead to complications over time, and some patients may require further procedures. One of the main issues is endoleak, which occurs when blood continues to flow into the aneurysm sac after treatment. This often happens because small nearby blood vessels, or other sources, continue to supply blood to the aneurysm.
A potentialy strategy to reduce the risk of endoleak is pre-emptive embolization-a technique used during EVAR to block these sources of persistent blood flow. This can include embolization of side branches, the aneurysm sac, or other contributing vessels. Early findings suggest that pre-emptive embolization may lower the risk of endoleaks, but it is still uncertain whether it improves long-term outcomes.
The PRIZE study (Randomized Controlled Trial on Pre-emptive Coil Embolization in Endovascular Aortic Repair) is designed to answer this question. In this research, patients are randomly assigned to one of two groups: one group will receive EVAR with pre-emptive embolization, and the other will receive EVAR without it.
Two main outcomes will be assessed. The first is aneurysm sac regression at two years, meaning a reduction in the size of the aneurysm sac after treatment. This is important because sac shrinkage after EVAR has been linked to lower overall mortality, even though the exact reasons for this are not yet fully understood. The second main outcome is the rate of aortic-related events over five years, as ensuring the long-term durability of treatment is a key goal of this study. Secondary outcomes, including quality of life, patient satisfaction, and cost-effectiveness will also be evaluated.
Currently, there is no clear agreement on whether pre-emptive embolization should be routinely used during EVAR. In a recent international survey, 76% of aortic specialists agreed that more evidence is needed. The PRIZE study aims to provide that evidence. If pre-emptive embolization proves effective, it could become a standard addition to EVAR, helping to improve both the immediate success and long-term durability of treatment. If not, the study will help avoid unnecessary procedures, ensuring patients receive only treatments that offer real benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVAR | Active comparator | Procedure: EVAREVAR, as per standard of care |
| EVAR + embolization | Experimental | Device: Concomitant embolization, Procedure: EVAREVAR, as per standard of care, associated with concomitant embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Abdominal aortic aneurysms with a maximum aortic diameter above the threshold for repair level.
- High-risk criteria for type 2 endoleaks
Key exclusion criteria (3 listed)
- Does not fulfill instructions for use for standard EVAR
- Contraindication for EVAR
- Life expectancy less than 2 years
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 |
|---|---|---|
| Concomitant embolizationThis will include EVAR, following the standard pathway of care, associated with embolization. The decision to perform side-branch embolization or aneurysm sac embolization will be left to each participating centre/physician. | Device | EVAR + embolization |
| EVAREndovascular aortic aneurysm repair | Procedure or surgery | EVAR, EVAR + embolization |
Primary outcome
Aneurysm sac regression at 2 years
Time frame: 24 months
Changes in the maximum aneurysm sac volume, which will be to assessed by an independent core lab.
Rate of aortic events at 5 years
Time frame: 60 months
The number of study participants with aortic events, including: * Aortic-related reinterventions * Development of type I/III, with or without reintervention * Development of T2EL with sac expansion >10mm with or without reintervention * Graft infection * Aneurysm rupture * Aortic-related death
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 16 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Concomitant embolization and EVAR in people with Abdominal Aneurysm and Endovascular Aortic Repair, run by Uppsala University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Carlota F. Prendes, MD, PhD (+46729621501, carlota.fernandez@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm sac regression at 2 years (time frame: 24 months). 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?
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 16 May 2025.