SUrgical Versus PERcutaneous AXillary Artery International Registry

Completed

• Conditions: Surgical and the Percutaneous Approach to the Upper Extremity Access
• Interventions: Other: access axillary or brachial artery

• Registration Number: NCT04589962
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-09
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous Group	access axillary or brachial artery	-
Surgical Group	access axillary or brachial artery	-

Primary Outcome Measures

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

Trial Locations

Locations (18)

UniversitätsSpital Zürich; 🇨🇭 Zürich, Switzerland

Ascension St John Hospital and Medical Center; 🇺🇸 Detroit, Michigan, United States

San Filippo Neri Hospital; 🇮🇹 Roma, Italy

S. Maria della Misericordia Hospital; 🇮🇹 Perugia, Italy

Medical University of Vienna; 🇦🇹 Vienna, Austria

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Service de Chirurgie Thoracique et Cardiovasculaire; 🇫🇷 Rennes, France

Imelda Hospital; 🇧🇪 Bonheiden, Belgium

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Skåne University Hospital; 🇸🇪 Malmö, Sweden

University hospital Leipzig; 🇩🇪 Leipzig, Germany

IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy

IRCCS San Raffaele; 🇮🇹 Milan, Italy

Nuffield Dept. of Clinical Neurosciences, University of Oxford; 🇬🇧 Oxford, United Kingdom

University Heart and Vascular Center Hamburg; 🇩🇪 Hamburg, Germany

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain

University Hospital of Cologne; 🇩🇪 Cologne, Germany