Radiation-free FEVAR with LumiGuide image guidance
Radiation Free Study
This study will test whether using LumiGuide instead of standard fluoroscopy cuts X‑ray time during fenestrated endovascular aortic repair for adults who need visceral artery incorporation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Locations | 9 sites (Birmingham, Alabama and 8 other locations) |
| Trial ID | NCT06549348 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, unblinded, multicenter comparison of LumiGuide image guidance versus conventional fluoroscopy during fenestrated endovascular aortic repair (FEVAR). Sites were chosen across the US and Europe to improve generalizability. The primary endpoint is average procedure fluoroscopy time measured for procedures that incorporate the celiac trunk, superior mesenteric artery, and renal arteries. Participants are adult patients undergoing primary FEVAR who meet vessel and timing eligibility and are randomized to LumiGuide or standard fluoroscopy guidance.
Who should consider this trial
Good fit: Adults (≥18 years) undergoing a primary FEVAR that includes incorporation of visceral arteries (celiac, SMA, renal), able to give informed consent, with life expectancy ≥2 years, and meeting the trial's vessel-count and timing criteria are ideal candidates.
Not a fit: Patients undergoing branched or iliac branched device procedures, staged or re-intervention FEVAR, emergent (<24 hr) repairs, treatment of more than four target vessels, or those with connective tissue disorders are excluded and unlikely to benefit from this trial's approach.
Why it matters
Potential benefit: If successful, the approach could substantially reduce patients' and staff's radiation exposure during complex aortic repair and may shorten imaging time.
How similar studies have performed: Prior studies of fusion imaging and navigation systems have shown reductions in fluoroscopy time for endovascular procedures, but randomized data specifically on LumiGuide are limited, making this a relatively novel randomized comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Birmingham, Alabama and 8 other locations
- University of Alabama — Birmingham, Alabama, United States (Not_yet_recruiting)
- University of Massachusetts — Worcester, Massachusetts, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- UZ Gent — Ghent, Belgium (Not_yet_recruiting)
- Rigshospitalet University Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Hôpital Universitaire Pitié-Salpêtrière — Paris, France (Not_yet_recruiting)
- UMC Maastricht — Maastricht, Netherlands (Not_yet_recruiting)
- Guys & St Thomas — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Bart Wessels
- Email: bart.wessels@philips.com
- Phone: bart.wessels@philips.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.