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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01480206
First received: November 23, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysm (AAA),
Thoracic Aortic Aneurysm (TAA),
Carotid Stenosis,
Visceral Artery Aneurysm
Other: Endovascular Aortic Repair (EVAR)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 3D Interventional Tools for Endovascular Procedures in the OR

Resource links provided by NLM:


Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • feedback to improve the usability of the Vessel Navigator [ Time Frame: one month after procedure ] [ Designated as safety issue: No ]
    PI answers questions to help improve the usability of the VesselNavigator


Estimated Enrollment: 140
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Endovascular Aortic Repair (EVAR)
    Use of 3D interventional imaging tools in endovascular procedures in the surgical environment
    Other Name: EVAR, TEVAR
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Patients already selected for endovascular treatment by preoperative CT angiogram Patients with preoperative CT performed within 4 months of operation

Criteria

Inclusion Criteria:

  • Patients with age 18-90, of both genders and all races
  • Patients undergoing elective AAA or TAA repair or carotid stenting
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480206

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Philips Healthcare
Investigators
Principal Investigator: Marc Schermerhorn, MD Beth Israel Deaconess Medical Center (BIDMC)
  More Information

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01480206     History of Changes
Other Study ID Numbers: XCY611-110165
Study First Received: November 23, 2011
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Carotid Stenosis
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 28, 2014