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出境医 / 临床实验 / Fusion Imaging for EVAR With Mobile C-arm (FUTUR)
Fusion Imaging for EVAR With Mobile C-arm (FUTUR)
Study Description
Brief Summary:
Fusion imaging is a technique that facilitates endovascular navigation but is only available in hybrid rooms. The goal of this study is to evaluate the feasibility of fusion imaging with a mobile C-arm in a conventional operating room through the use of an angio-navigation station.
| Condition or disease | Intervention/treatment |
|---|---|
| Fusion Imaging for EVAR | Other: Fusion imaging |
Detailed Description:
The study include all patients who underwent an aortic stent graft procedure in a conventional operating room with a mobile flat-panel detector (Cios Alpha, Siemens) connected to an angio-navigation station (EndoNaut, Therenva). The intention is to perform preoperative 3D CT/perioperative 2D fluoroscopy fusion Imaging using an automatic registration process. Registration is considered successful when the software was able to correctly overlay preoperative 3D vascular structures onto the fluoroscopy image. For EVAR, contrast dose, operation and fluoroscopy time were compared to those of a control group drawn from the department's database who underwent a procedure with a C-arm image intensifier.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 59 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Feasibility of Computer-assisted Aortic and Iliac Endovascular Procedures With Mobile C-arm |
| Actual Study Start Date : | January 1, 2016 |
| Actual Primary Completion Date : | July 19, 2016 |
| Actual Study Completion Date : | February 2, 2018 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| EVAR aneurysm |
Other: Fusion imaging
Fusion imaging during aortic endovascular procedures with a mobile C-arm through the use of the EndoNaut® angio-navigation station
|
| Stenosis |
Other: Fusion imaging
Fusion imaging during aortic endovascular procedures with a mobile C-arm through the use of the EndoNaut® angio-navigation station
|
Outcome Measures
Primary Outcome Measures :
- Feasibility of fusion imaging [ Time Frame: 6 months ]To evaluate the feasibility of fusion imaging during aortic endovascular procedures with a mobile C-arm through the use of the EndoNaut® angio-navigation station
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients eligible for endovascular treatment of aneurysm disease of the aorta.
Criteria
Inclusion Criteria:
Patients eligible for endovascular treatment of aneurysm disease of the aorta. Procedure performed in a conventional operating room equipped with a mobile flat-panel detector (30´30 cm) (Cios-Alpha, Siemens®, Munich, Germany) and a floating table.
Patients who received written and verbal information about the protocol and did not object to participating in the trial.
Exclusion Criteria:
Patients who also required a conventional surgical revascularisation procedure or who required an endovascular revascularisation procedure in another site.
Patients who underwent MR angiography during preoperative evaluation. Non-analysable CT angiogram (no or poor injection). Procedure performed in a hybrid room or in an operating room not equipped with a mobile flat-panel detector.
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 2, 2019 | ||||
| First Posted Date | July 5, 2019 | ||||
| Last Update Posted Date | July 5, 2019 | ||||
| Actual Study Start Date | January 1, 2016 | ||||
| Actual Primary Completion Date | July 19, 2016 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Feasibility of fusion imaging [ Time Frame: 6 months ] To evaluate the feasibility of fusion imaging during aortic endovascular procedures with a mobile C-arm through the use of the EndoNaut® angio-navigation station
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Fusion Imaging for EVAR With Mobile C-arm | ||||
| Official Title | Feasibility of Computer-assisted Aortic and Iliac Endovascular Procedures With Mobile C-arm | ||||
| Brief Summary | Fusion imaging is a technique that facilitates endovascular navigation but is only available in hybrid rooms. The goal of this study is to evaluate the feasibility of fusion imaging with a mobile C-arm in a conventional operating room through the use of an angio-navigation station. | ||||
| Detailed Description | The study include all patients who underwent an aortic stent graft procedure in a conventional operating room with a mobile flat-panel detector (Cios Alpha, Siemens) connected to an angio-navigation station (EndoNaut, Therenva). The intention is to perform preoperative 3D CT/perioperative 2D fluoroscopy fusion Imaging using an automatic registration process. Registration is considered successful when the software was able to correctly overlay preoperative 3D vascular structures onto the fluoroscopy image. For EVAR, contrast dose, operation and fluoroscopy time were compared to those of a control group drawn from the department's database who underwent a procedure with a C-arm image intensifier. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients eligible for endovascular treatment of aneurysm disease of the aorta. | ||||
| Condition | Fusion Imaging for EVAR | ||||
| Intervention | Other: Fusion imaging
Fusion imaging during aortic endovascular procedures with a mobile C-arm through the use of the EndoNaut® angio-navigation station
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
59 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | February 2, 2018 | ||||
| Actual Primary Completion Date | July 19, 2016 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria: Patients eligible for endovascular treatment of aneurysm disease of the aorta. Procedure performed in a conventional operating room equipped with a mobile flat-panel detector (30´30 cm) (Cios-Alpha, Siemens®, Munich, Germany) and a floating table. Patients who received written and verbal information about the protocol and did not object to participating in the trial. Exclusion Criteria: Patients who also required a conventional surgical revascularisation procedure or who required an endovascular revascularisation procedure in another site. Patients who underwent MR angiography during preoperative evaluation. Non-analysable CT angiogram (no or poor injection). Procedure performed in a hybrid room or in an operating room not equipped with a mobile flat-panel detector. |
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04008212 | ||||
| Other Study ID Numbers | 35RC15_3020 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Rennes University Hospital | ||||
| Study Sponsor | Rennes University Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Rennes University Hospital | ||||
| Verification Date | July 2019 | ||||
