BridgeMD
New treatment option for Aortic Aneurysm
Official title Radiation Free Study
ClinicalTrials.gov ID: NCT06549348
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including people with prior infrarenal EVAR or open...
- 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
You likely can't join if
- people 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
- people 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
See the full eligibility criteria
- Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including people with prior infrarenal EVAR or open repair) that includes the incorporation of visceral arteries into the...
- 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
- people 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
- people 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 people such as immuno-compromised people, people lacking the capacity to provide consent, patients in emergency situations, pregnant or breast-feeding women, or any other subject who meets an exclusion...
- Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Ghent, Belgium
- Copenhagen, Denmark
- Paris, France
- Maastricht, Netherlands
- Utrecht, Netherlands
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Boston, Massachusetts, United States; Worcester, Massachusetts, United States; Philadelphia, Pennsylvania, United States; Dallas, Texas, United States; Ghent, Belgium and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.