Clinical trial NCT01480206: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm (AAA)
Thoracic Aortic Aneurysm (TAA)
Carotid Stenosis
Visceral Artery Aneurysm
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2011-11-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: feedback to improve the usability of the Vessel Navigator
timeFrame: one month after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Marc Schermerhorn, MD
role: PRINCIPAL_INVESTIGATOR
References: