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SUrgical Versus PERcutaneous AXillary Artery International Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04589962
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bertoglio Luca, 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.

Condition or disease Intervention/treatment
Surgical and the Percutaneous Approach to the Upper Extremity Access Other: access axillary or brachial artery

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: SUrgical Versus PERcutaneous AXillary Artery International Registry A Physician-initiated, International, Multicentric, Retrospective, Observational, Voluntary Registry - SUPER AXA International Registry
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : April 30, 2021

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




Primary Outcome Measures :
  1. optimal hemostasis [ Time Frame: 30 days ]
    Closure success rate of the procedure without any adjunctive procedures

  2. vascular complications [ Time Frame: 30 days ]
    freedom from major access vascular complications requiring adjunctive endovascular or open procedures

  3. Incidence of permanent peripheral nerve injury [ Time Frame: 30 days ]
    freedom from permanent peripheral nerve injury with functional compromise

  4. stroke Incidence [ Time Frame: periprocedural ]
    freedom from periprocedural stroke

  5. Durability of vessel closure [ Time Frame: 30 days ]
    freedom from secondary intervention at access site



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589962


Contacts
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Contact: Luca Bertoglio, MD +39 0226437381 bertoglio.luca@hsr.it

Locations
Show Show 18 study locations
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Principal Investigator: Luca Bertoglio, MD IRCCS San Raffaele Hospital
Publications of Results:
Other Publications:

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Responsible Party: Bertoglio Luca, Principal Investigator, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04589962    
Other Study ID Numbers: SUPER AXAInternationalRegistry
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No