SUrgical Versus PERcutaneous AXillary Artery International Registry
Completed
Conditions studied: Surgical and the Percutaneous Approach to the Upper Extremity Access
In brief
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.
Key facts
- Study ID
- NCT04589962
- Run by
- IRCCS San Raffaele
- People needed
- 700
- Starts
- 2020-10-09
- Expected to finish
- 2022-02-28
- Last updated by the study team
- 2022-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- 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
- IRCCS San Raffaele — Milan, Italy
- S. Maria della Misericordia Hospital — Perugia, Italy
- San Filippo Neri Hospital — Roma, Italy
- Hospital General Universitario Gregorio Marañón — Madrid, Spain
- Hospital Álvaro Cunqueiro — Vigo, Spain
- Skåne University Hospital — Malmö, Sweden
- UniversitätsSpital Zürich — Zurich, Switzerland
- Nuffield Dept. of Clinical Neurosciences, University of Oxford — Oxford, United Kingdom
Full record on ClinicalTrials.gov
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