Abdominal Aortic Aneurysm (AAA)NCT01480206
Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR
An observational study of Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic Aneurysm (TAA), run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Abdominal Aortic Aneurysm (AAA), Thoracic Aortic Aneurysm (TAA), Carotid Stenosis
- What is being tested?
- Endovascular Aortic Repair (EVAR)
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2011to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: 3D Interventional Tools for Endovascular Procedures in the OR
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm (AAA), Thoracic Aortic Aneurysm (TAA), Carotid Stenosis, Visceral Artery Aneurysm
- Being tested
- Endovascular Aortic Repair (EVAR)
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aortic Repair (EVAR)Other
Also called EVAR, TEVAR
Use of 3D interventional imaging tools in endovascular procedures in the surgical environment
What is being measured
The primary outcome is the main question the study is designed to answer.
feedback to improve the usability of the Vessel Navigator
PI answers questions to help improve the usability of the VesselNavigator
Measured: one month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study start13 Sep 2011
- Primary completion1 Apr 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysm (AAA)Studies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Schermerhorn, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480206
- Sponsor's protocol ID
- XCY611-110165
- Status last verified
- Dec 2024
- First submitted
- 23 Nov 2011
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Interventional Tools for Endovascular Procedures in the OR
- ClinicalTrials.gov ID
- NCT01480206
- Acronym / sponsor ID
- XCY611-110165
- Conditions
- Abdominal Aortic Aneurysm (AAA), Thoracic Aortic Aneurysm (TAA), Carotid Stenosis, Visceral Artery Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2011 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 28 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Aortic Repair (EVAR)Also: EVAR, TEVARUse of 3D interventional imaging tools in endovascular procedures in the surgical environment | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Schermerhorn, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic Aneurysm (TAA), run by Philips Clinical & Medical Affairs Global at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feedback to improve the usability of the Vessel Navigator (time frame: one month after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.