SUrgical Versus PERcutaneous AXillary Artery International Registry

San Donato Group (GSD)

Status: Completed

Conditions: Surgical and the Percutaneous Approach to the Upper Extremity Access

Treatments: Other: access axillary or brachial artery

Study type: Observational

Funder types: Other

Identifiers

NCT04589962

SUPER AXAInternationalRegistry

Details and patient eligibility

About

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.

Enrollment: 700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

700 participants in 2 patient groups

Percutaneous Group

Treatment:

Other: access axillary or brachial artery

Surgical Group

Treatment:

Other: access axillary or brachial artery