Status:
COMPLETED
Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Abdominal Aortic Aneurysm (AAA)
Thoracic Aortic Aneurysm (TAA)
Eligibility:
All Genders
18-90 years
Brief 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 ...
Detailed Description
Endovascular treatment is performed under the guidance of an X-ray angiography system. Fluoroscopy and conventional 2D digital subtraction angiography (DSA) are used to navigate the interventional dev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 13 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01480206
Start Date
September 13 2011
End Date
August 1 2021
Last Update
December 19 2024
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215