Aortic AneurysmRadFreeNCT06549348
Radiation Free Study
A study testing Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance in people with Aortic Aneurysm, run by Philips Clinical & Medical Affairs Global at 11 sites in 6 countries.
Trial summary
This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 3 Jul 2025to 30 Jun 2027
- 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
- Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including subjects with prior infrarenal EVAR or open repair) that includes the incorporation of visceral arteries into the repair.
- Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law.
- Subject has a life expectancy of at least 2 years
- Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and Renal Arteries
Who cannot join
- Subjects undergoing an endovascular procedure that include branches or iliac branched devices (IBD) in the repair
- Subject treated for re-intervention / staged procedure post-primary FEVAR procedure
- Subjects intended to be treated for more than 4 target vessels (not counting the contralateral gate)
- Subject treated for an emergent (<24hrs after emergence) procedure
- Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome
- Subject with contrast allergies
Show all 9Show fewer
- Subject participates in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips.
- All vulnerable subjects such as immuno-compromised subjects, subjects lacking the capacity to provide consent, patients in emergency situations, pregnant or breast-feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any.
- Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent
Trial locations and contacts
11 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 6 countries
United States5 sites, 5 recruiting
- Recruiting
University of Alabama
Birmingham, Alabama, 35249
Adam Beck
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Marc Schermerhorn
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Mirza Baig
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Darren Schneider
- Recruiting
University of Massachusetts
Worcester, Massachusetts, 01655
Andres Schanzer
Netherlands2 sites, 2 recruiting
- Recruiting
UMC Maastricht
Maastricht
Geert-Willem Schurink
- Not yet recruiting
University Medical Center Utrecht
Utrecht, 3508GA
Joost van Herwaarden
Denmark1 site, 1 recruiting
- Not yet recruiting
Rigshospitalet University Hospital
Copenhagen
Timothy Resch
France1 site, 1 recruiting
- Recruiting
Hôpital Universitaire Pitié-Salpêtrière
Paris
Laurent Chiche
United Kingdom1 site, 1 recruiting
- Recruiting
Guys & St Thomas
London
Bijan Modarai
About this study
This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.
Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)
- Conditions
- Aortic Aneurysm
- Being tested
- Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidanceRadiation
Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance
| Study group | Role | What they receive |
|---|---|---|
| Task navigation using fluoroscopy guidance | No intervention | Standard of care treatment using |
| Task navigation using LumiGuide | Active comparator | Standard of care treatment using LumiGuide fluoroscopy guidance Receives: Radiation: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR).
Procedure fluoroscopy time
Measured: Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start3 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic 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
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549348
- Sponsor's protocol ID
- IGT-00915-RadFree
- Acronym
- RadFree
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Free Study
- ClinicalTrials.gov ID
- NCT06549348
- Acronym / sponsor ID
- RadFree / IGT-00915-RadFree
- Conditions
- Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Aug 2024 (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.
This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.
Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task navigation using fluoroscopy guidance | No intervention | –Standard of care treatment using |
| Task navigation using LumiGuide | Active comparator | Radiation: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidanceStandard of care treatment using LumiGuide fluoroscopy guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including subjects with prior infrarenal EVAR or open repair) that includes the incorporation of visceral arteries into the repair.
- Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law.
- Subject has a life expectancy of at least 2 years
- Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and Renal Arteries
Key exclusion criteria (9 listed)
- Subjects undergoing an endovascular procedure that include branches or iliac branched devices (IBD) in the repair
- Subject treated for re-intervention / staged procedure post-primary FEVAR procedure
- Subjects intended to be treated for more than 4 target vessels (not counting the contralateral gate)
- Subject treated for an emergent (<24hrs after emergence) procedure
- Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome
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 |
|---|---|---|
| Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidanceFenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance | Radiation | Task navigation using LumiGuide |
Primary outcome
To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR).
Time frame: Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)
Procedure fluoroscopy time
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 15 Jun 2026.
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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.
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance in people with Aortic Aneurysm, run by Philips Clinical & Medical Affairs Global at 11 sites in 6 countries.
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 4 inclusion and 9 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Netherlands, Belgium, Denmark, France and 1 more country. 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 Bart Wessels (bart.wessels@philips.com, bart.wessels@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR). (time frame: Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)). 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 15 Jun 2026.