Completed

NCT Number: NCT04589962

SUrgical Versus PERcutaneous AXillary Artery International Registry

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.

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Key information

Conditions

Surgical and the Percutaneous Approach to the Upper Extremity Access

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

access axillary or brachial artery

Other

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

Primary outcomes

optimal hemostasis

Time frame: 30 days

Closure success rate of the procedure without any adjunctive procedures
vascular complications

Time frame: 30 days

freedom from major access vascular complications requiring adjunctive endovascular or open procedures
Incidence of permanent peripheral nerve injury

Time frame: 30 days

freedom from permanent peripheral nerve injury with functional compromise
stroke Incidence

Time frame: periprocedural

freedom from periprocedural stroke
Durability of vessel closure

Time frame: 30 days

freedom from secondary intervention at access site

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 19, 2020
Registry last updated: Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.