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

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Abdominal aortic aneurysm
Related Access Program
Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

Official Title

3D Interventional Tools for Endovascular Procedures in the OR

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.

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

Observational

Primary Outcome

feedback to improve the usability of the Vessel Navigator

Condition

Abdominal Aortic Aneurysm (AAA)

Intervention

Endovascular Aortic Repair (EVAR)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

58

Start Date

September 13, 2011

Completion Date

August 1, 2021

Primary Completion Date

April 1, 2021

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Marc Schermerhorn, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01480206

Organization ID

XCY611-110165

Responsible Party

Sponsor

Study Sponsor

Philips Clinical & Medical Affairs Global

Study Sponsor

Marc Schermerhorn, MD, Principal Investigator, Beth Israel Deaconess Medical Center

Verification Date

March 2022