Radiation-free FEVAR with LumiGuide image guidance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama
  Birmingham, Alabama, United States 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 Recruiting
• Hôpital Universitaire Pitié-Salpêtrière
  Paris, France Recruiting

Study contacts

• Study coordinator: Bart Wessels
• Email: bart.wessels@philips.com
• Phone: bart.wessels@philips.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Physician-modified endografts for aortic disease in high-risk patients

  This study tests a physician-modified Terumo Treo abdominal stent-graft to see if it can safely treat large aortic aneurysms in patients who are high-risk for open surgery.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT07611968

• Using AI to measure aortic size from CT scans

  This project will test whether an AI tool called Aorta AIM can automatically measure the aorta on CT scans for adults who have or are being checked for aortic aneurysms.

  Recruiting Aiatella Oy · Chapel Hill, North Carolina and 2 other locations · NCT07438327

• Measuring the shape and strength of the ascending aorta in patients having heart surgery

  We will test whether direct measurements of the aortic wall's mechanical properties taken during heart surgery can better characterize rupture or dissection risk in people with ascending aortic aneurysm by comparing them to patients undergoing heart transplantation without known aortic disease.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Lombardy · NCT07422129

• Rapidlink device for repairing aortic arch branch vessels during open thoracic aorta surgery

  This study will test whether the Rapidlink device can help surgeons repair or replace the arteries branching from the aortic arch during open surgery for thoracic aortic disease.

  Recruiting at 7 sites Vascutek Ltd. · Los Angeles, California and 20 other locations · NCT07078383

• Using modified endovascular grafts to treat complex aortic aneurysms

  This study is testing if specially modified grafts can safely repair complex aortic aneurysms in high-risk patients who can’t have regular surgery.

  Recruiting Hartford Hospital · Hartford, Connecticut · NCT06834607

• Understanding exercise effects on aortic aneurysm patients

  This study is testing how exercise affects people with aortic aneurysms to help find safe activity levels that could improve their health.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT06789809

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.