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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00645-44 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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This is a randomized prospective monocentric study to evaluate the benefits of a 3D rotational acquisition (3DRA) to assess technical success after treatment of infra-renal aneurysm with bifurcated endograft. Patients will be randomized between the standard strategy (2D angiography at the end of the procedure and angioCT-scan before discharge) and the new strategy (3DRA at the end of the procedure). Expected findings are a reduction of radiation exposure and contrast medium used during the hospital stay, with a similar resolution between angioCT-scan and 3DRA to depict the main complications after EVAR (occlusion, kinking, endoleak). Furthermore, any complication depicted after 3DRA group could benefit from an additional procedure during the same operating time, and therefore avoid a second intervention for the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D Angiography (2DA) | No Intervention | Standard of care - Patients benefit from a 2D completion angiogram at the end of the procedure, and from a angioCT-scan before discharge. If any technical issues is depicted on the CT-scan, a new intervention needs to be scheduled. | |
| 3D rotational angiography (3DRA) | Experimental | New strategy - Patients benefit from a 3D rotational acquisition at the end of procedure, which offers CT-like reconstructions. If any technical issues is depicted on the 3DRA, it can be treated during the same operating time. A contrast-enhanced ultrasound is performed for each patient before discharge to confirm that no technical issue was missed by the 3DRA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D rotational angiography (3DRA) | Radiation | 3DRA allows CT-like reconstructions. It requires less X-rays and contrast medium than standard angioCT-scan. Furthermore, it can be performed in the operative room, during the procedure. Therefore, use of 3DRA should allow reduction of dose, contrast-medium and reintervention when compared to technical success assessment with angioCT-scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Dose | Total exposure to radiation in mSv | Single 1 day - At patient discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Medium | Total amount of contrast medium used (mg of Iodine) | Single 1 day - At patient discharge |
| Reintervention rate | Number of secondary procedures due to initial technical issues in both group during the first month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Haulon, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cardiologique, CHRU | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28546044 | Result | Clough RE, Martin-Gonzalez T, Van Calster K, Hertault A, Spear R, Azzaoui R, Sobocinski J, Haulon S. Endovascular Repair of Thoracoabdominal and Arch Aneurysms in Patients with Connective Tissue Disease Using Branched and Fenestrated Devices. Ann Vasc Surg. 2017 Oct;44:158-163. doi: 10.1016/j.avsg.2017.05.013. Epub 2017 May 22. |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| During the first 30 days |
| Additional procedure | Number of additional unplanned procedures during the initial operating time, thanks to complications depicted by respectively the 2D angiography or the 3D rotational angiography. | During surgery |
| D001018 |
| Aortic Diseases |