Branched Aortic Arch Study

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the safety and effectiveness of endovascular treatment of aortic aneurysms involving the proximal aortic arch. The investigational operation involves placing a stent-graft over the aortic aneurysm.

Detailed Description
-----------------
An aneurysm is a localized bulge in the wall of an artery. Aneurysms of the aorta are prone to progressive dilatation, which if left untreated ultimately results in rupture, internal bleeding and death. Traditional open surgery involves aortic exposure through a long incision, aortic clamping to interrupt blood flow, and replacement or repair of the dilated aortic segment using a fabric conduit (graft), which is sutured (anastomosis) to the nondilated arteries above and below the aneurysm. Some subjects are able to withstand such a large operation better than others, but many suffer complications, and all suffer pain, debility, and a lengthy stay in hospital. Endovascular aneurysm repair is a less invasive alternative that substitutes a trans-arterial route to the aneurysm for direct exposure, and stent-mediated attachment for sutured anastomosis. Compared to open surgical repair, endovascular repair is associated with less physiological derangement, less pain, less blood loss, lower complication rates and shorter hospital stay. Consequently, endovascular repair has become standard therapy for aneurysms of the abdominal aorta and descending thoracic aorta, where there are no vital branches and endovascular exclusion rarely causes ischemic complications. Open surgical repair of the proximal aortic arch requires hypothermic circulatory arrest, because it deprives the heart of its outflow and the brain of its inflow. Endovascular repair also obstructs outflow from the heart, but only for a few seconds, while the graft is released from its delivery sheath. The greater problem is inflow to the brain. In anticipation of aortic arch exclusion, the brachiocephalic circulation requires an alternative source of blood. One alternative is bypass from the ascending aorta. However, this requires median sternotomy and partial aortic clamping, both of with are potential sources of morbidity.

Official Title
-----------------
Branched Stent-Graft Repair for Endo Repair of Aneurysms Involving the Proximal Aortic Arch

Conditions
-----------------
Aortic Aneurysm of the Proximal Arch

Intervention / Treatment
-----------------
* Device: Endovascular Bifurcated Stent-Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aneurysm of the aortic arch larger than 6cm in diameter, or symptomatic aneurysm of the aortic arch, of any diameter, or any arch aneurysm with a 2-year rupture rate estimated to be more than 20%. Anticipated mortality rate with open repair estimated to be more than 20%. Suitable arterial anatomy for stent-graft Life expectancy more than 2 years Ability to give informed consent and willingness to comply with follow-up schedule Exclusion Criteria: Free rupture of the aneurysm Pregnancy Anaphylactic reaction to contrast material Allergy to stainless steel or polyester Unwillingness or inability to comply with the follow-up schedule Serious systemic or groin infection Uncorrectable coagulopathy Significant presence of carotid artery atherosclerosis Arrhythmia define as 2nd- and 3rd-degree atrioventricular block or sinus node disease, such as sick sinus syndrome and symptomatic bradycardia, unless the patient already has a pacemaker in place and cardiology consultation confirms that it is safe to proceed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Endovascular Bifurcated Stent Graft: The investigational operation involves placing a stent-graft over the aortic aneurysm. | Device: Endovascular Bifurcated Stent-Graft<br>* Treatment of Aneurysm involving the proximal aortic arch with endovascular bifurcated stent-graft.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful implantation of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aneurysm, Aortic Arch, Endovascular, Stent-Graft