SUrgical Versus PERcutaneous AXillary Artery International Registry

Completed

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

• 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

Primary Outcome Measures

Name	Time	Method
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
Durability of vessel closure	30 days	freedom from secondary intervention at access site

Trial Locations

Locations (18)

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

Medical University of Vienna; 🇦🇹 Vienna, Austria

Imelda Hospital; 🇧🇪 Bonheiden, Belgium

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

University Hospital of Cologne; 🇩🇪 Cologne, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

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

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

University hospital Leipzig; 🇩🇪 Leipzig, Germany

IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy

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