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

NCT01480206 | Completed

• 1 other identifier: XCY611-110165
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Abdominal Aortic Aneurysm (AAA); Thoracic Aortic Aneurysm (TAA); Carotid Stenosis; Visceral Artery Aneurysm

Outcome Measures

Primary Outcomes (1)

• feedback to improve the usability of the Vessel Navigator

  PI answers questions to help improve the usability of the VesselNavigator

  one month after procedure

Interventions

Endovascular Aortic Repair (EVAR) OTHER

Use of 3D interventional imaging tools in endovascular procedures in the surgical environment

Also known as: EVAR, TEVAR

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Carotid Stenosis

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Marc Schermerhorn, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: September 13, 2011
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

US (1)