CompletedNot Applicable

Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR

United States58 participantsStarted 2011-09-13

Plain-language summary

As endovascular procedures become more complex, there is a growing need for 3D image overlay to assist with device guidance and placement. Currently, a 3D image is typically created intra-operatively using 3D rotational angiography (3D-RA) or cone-beam CT (XperCT). This 3D image may then be overlaid on live fluoroscopy to provide 3D guidance information (Dynamic 3D Roadmapping). Philips Healthcare multimodality overlay products allows registration of a pre-acquired MR/CT or 3D rotational image to live fluoroscopy.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with age 18-90, of both genders and all races * Patients undergoing elective AAA or TAA repair or carotid stenting or peripheral intervention * Patients already selected for endovascular treatment by preoperative CT angiogram * Patients with preoperative CT performed within 4 months of operation Exclusion Criteria: * Patients refusing or incapable of providing informed consent * Patients undergoing emergent or ruptured AAA repair * Patients with known connective tissue disorders * Patients with aortic dissections * Patients participating in other EVAR, IDE, or IND trials * Patients with anticipated adjunctive intervention requiring additional intravenous contrast * Patients with anticipated endograft extension distal to the common iliac artery * Patients without CT angiogram performed at BIDMC with standard EVAR protocol * Patients without CT angiogram performed within 4 months of operation * Patients with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 * Patients with contraindication to intravenous contrast * Patients with disability or previous implants precluding adequate visualization on rotational imaging

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

feedback to improve the usability of the Vessel Navigator

Timeframe: one month after procedure

Trial details

NCT IDNCT01480206

SponsorPhilips Clinical & Medical Affairs Global

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-04-01

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm (AAA) trials