SUrgical Versus PERcutaneous AXillary Artery International Registry

November 10, 2022 updated by: Bertoglio Luca, IRCCS San Raffaele

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna
  • Belgium
      • Bonheiden, Belgium
        • Imelda Hospital
  • France
      • Rennes, France
        • Service de Chirurgie Thoracique et Cardiovasculaire
  • Germany
      • Cologne, Germany
        • University Hospital of Cologne
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Hamburg, Germany
        • University Hospital Hamburg-Eppendorf
      • Hamburg, Germany
        • University Heart and Vascular Center Hamburg
      • Leipzig, Germany
        • University Hospital Leipzig
  • Italy
      • Milan, Italy, 20132
        • IRCCS San Raffaele
      • Milan, Italy, 20132
        • IRCCS San Raffaele Hospital
      • Perugia, Italy
        • S. Maria della Misericordia Hospital
      • Roma, Italy
        • San Filippo Neri Hospital
  • Spain
      • Madrid, Spain
        • Hospital General Universitario Gregorio Maranon
      • Vigo, Spain
        • Hospital Álvaro Cunqueiro
  • Sweden
      • Malmö, Sweden
        • Skane University Hospital
  • Switzerland
      • Zürich, Switzerland
        • Universitätsspital Zürich
  • United Kingdom
      • Oxford, United Kingdom
        • Nuffield Dept. of Clinical Neurosciences, University of Oxford
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Ascension St John Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated between January 2010 and May 2020 for a condition involving the aortic valve or the aorta and/or its side branches with procedures requiring an upper extremity access at the level of the axillary or brachial artery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Percutaneous Group
Other: access axillary or brachial artery
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
Surgical Group
Other: access axillary or brachial artery
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Luca Bertoglio, MD, IRCCS San Raffaele Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 9, 2020

Primary Completion (ACTUAL)

February 28, 2022

Study Completion (ACTUAL)

February 28, 2022

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • SUPER AXAInternationalRegistry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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