SUrgical Versus PERcutaneous AXillary Artery International Registry

Study Overview
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Brief Summary
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The purpose of the Study is to compare the outcomes of the surgical and the percutaneous approach to the upper extremity access (axillary or brachial artery) during endovascular procedures on the aortic valve, the aorta, and its side branches.

Official Title
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SUrgical Versus PERcutaneous AXillary Artery International Registry A Physician-initiated, International, Multicentric, Retrospective, Observational, Voluntary Registry - SUPER AXA International Registry

Conditions
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Surgical and the Percutaneous Approach to the Upper Extremity Access

Intervention / Treatment
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* Other: access axillary or brachial artery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who received a surgical or percutaneous access to the axillary or brachial artery during Transcatheter Aortic Valve Implantation (TAVI), Fenestrated/Branched-Endovascular Aortic Repair (F/BEVAR), chimney-EVAR (Ch-EVAR) or visceral side branches stenting, between January 2010 and May 2020 Adult patients ≥18 years Exclusion Criteria: Introducer sheath internal diameter (ID) used < 5F or > 22F Patient with previous surgical axillary access on the puncture side (Pacemaker excluded) Patient with subclavian / axillary / brachial occlusive disease with stenosis greater than 50% Patient with previous bypass surgery or stent placement in the vicinity of access site (ie. Axillary extracorporeal cannulation with, axillo-femoral bypass, patch (venous or synthetic repair of previous axillary access, etc) Bleeding diathesis or coagulopathy Patients with active systemic or cutaneous infection or inflammation Patients who are pregnant or lactating Patient younger than 18 years of age Patients who are morbidity obese (BMI > 40 Kg/m2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Percutaneous Group<br> | Other: access axillary or brachial artery<br>* access to the axillary or brachial artery during Transcatheter Aortic Valve Implantation (TAVI), Fenestrated/Branched-Endovascular Aortic Repair (F/BEVAR), chimney-EVAR (Ch-EVAR) or visceral side branches stenting<br>|
| Surgical Group<br> | Other: access axillary or brachial artery<br>* access to the axillary or brachial artery during Transcatheter Aortic Valve Implantation (TAVI), Fenestrated/Branched-Endovascular Aortic Repair (F/BEVAR), chimney-EVAR (Ch-EVAR) or visceral side branches stenting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optimal hemostasis | Closure success rate of the procedure without any adjunctive procedures | 30 days | 
| vascular complications | freedom from major access vascular complications requiring adjunctive endovascular or open procedures | 30 days | 
| Incidence of permanent peripheral nerve injury | freedom from permanent peripheral nerve injury with functional compromise | 30 days | 
| stroke Incidence | freedom from periprocedural stroke | periprocedural | 
| Durability of vessel closure | freedom from secondary intervention at access site | 30 days |