- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01480206
Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR
3D Interventional Tools for Endovascular Procedures in the OR
Study Overview
Status
Conditions
Intervention / Treatment
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 device (and implant) across the lesion to achieve a correct bridging of the diseased region of the vessel, while excluding the involvement of patent vessels. Drawbacks of these peripheral interventions include the radiation dose, use of contrast, and need for a clinician with excellent wire-handling skills. The use of 2D imaging alone may not be enough to describe the three-dimensional(3D) relationship between interventional devices (and implants) and the complex vascular anatomy, often making positioning, deployment and evaluation suboptimal. In addition, the endovascular approach can lead to complications such as in-stent thrombosis and type II endoleak (in the case of aortic aneurysms) for which 2D imaging along is again sub-optimal for re-intervention planning and guidance.
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). 3D navigation can also be acquired by registration of a pre-acquired MR/CT or 3D rotational image to live fluoroscopy.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
feedback to improve the usability of the Vessel Navigator
Time Frame: one month after procedure
|
PI answers questions to help improve the usability of the VesselNavigator
|
one month after procedure
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Carotid Artery Diseases
- Aortic Diseases
- Carotid Stenosis
- Aneurysm
- Aortic Aneurysm
- Aortic Aneurysm, Abdominal
- Aortic Aneurysm, Thoracic
Other Study ID Numbers
- XCY611-110165
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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