Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO)

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO)

Official Title

Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO)

Brief Summary

      Purpose of the study is the evaluation of the applicability of the percutaneous technique
      through double Proglide and Pre-Close Technique to the treatment of complex aortic aneurysms
      with thoracic endoprosthesis (TEVAR), fenestrated or branched (F / B-EVAR) in which
      patient-related factors, the devices used or the procedure, could affect the performance.

Detailed Description

      Endovascular treatment using a percutaneous technique (Percutaneous Endovascular Aneurism
      Repair - P-EVAR) has been used with increasing frequency to treat aortic aneurysms by
      reducing operative times, postoperative pain and length of stay, compared to treatment by
      surgical femoral access. During EVAR procedures, two accesses to the femoral arteries are
      required to introduce the necessary tools for the stentgraft implantation. Such accesses can
      be classically obtained by surgical incision, isolation of the common femoral arteries and
      direct introduction of the devices.

      Alternatively, the most modern approach involves direct puncture of the artery (without the
      need for incision), through the skin and closure of the arterial breach through prolonged
      manual compression of the vascular closure or systems (Vascular Closure Devices - VCD)
      specifically designed. Among the various closure devices one of the most used and studied is
      the Perclose Proglide (Abbott Vascular, Santa Clara CA, USA) that allows to affix a
      polypropylene stitch to close the arterial breach. When closing high-caliber accesses (> 8
      French) it is necessary to use two devices that must be positioned before inserting the
      introducer ("Pre-Close Technique").

      Few studies have so far evaluated the application of this method to the treatment of complex
      cases such as thoracic or thoracoabdominal aortic aneurysms that requiring the use of high
      caliber introducers.

      The objective of the study is the evaluation of the technical success and clinical outcomes
      of the PEVAR technique with a double vascular suture device Perclose ProGlide (Abbott
      Illinois, U.S.A.).Endovascular treatment using a percutaneous technique (Percutaneous
      Endovascular Aneurism Repair - P-EVAR) has been used with increasing frequency to treat
      aortic aneurysms by reducing operative times, postoperative pain and length of stay, compared
      to treatment by surgical femoral access. During EVAR procedures, two accesses to the femoral
      arteries are required to introduce the necessary tools for the stentgraft implantation. Such
      accesses can be classically obtained by surgical incision, isolation of the common femoral
      arteries and direct introduction of the devices.

      Alternatively, the most modern approach involves direct puncture of the artery (without the
      need for incision), through the skin and closure of the arterial breach through prolonged
      manual compression of the vascular closure or systems (Vascular Closure Devices - VCD)
      specifically designed. Among the various closure devices one of the most used and studied is
      the Perclose Proglide (Abbott Vascular, Santa Clara CA, USA) that allows to affix a
      polypropylene stitch to close the arterial breach. When closing high-caliber accesses (> 8
      French) it is necessary to use two devices that must be positioned before inserting the
      introducer ("Pre-Close Technique").

      Few studies have so far evaluated the application of this method to the treatment of complex
      cases such as thoracic or thoracoabdominal aortic aneurysms that requiring the use of high
      caliber introducers.

      The objective of the study is the evaluation of the technical success and clinical outcomes
      of the PEVAR technique with a double vascular suture device Perclose ProGlide (Abbott
      Illinois, U.S.A.).

      This is a retrospective observational study (320 cases treated in San Raffaele hospital in
      Milan, during the period: October 2015 - 31 December 2019).

      The chronology of the assessments will include:

        -  An immediate evaluation at the end of the procedure by performing the ecocolordoppler
           examination of the percutaneous accesses performed (as per routine). On the basis of
           longitudinal and sagittal scans of the vessel, the Physician must check the presence of
           the above complications that could be considered as "failure" of percutaneous access. In
           the event that these complications are clinically evident (eg uncontrollable bleeding
           from the puncture site), in the interest of a prompt management of the surgical problem,
           it will not be necessary to perform an ecocolordoppler examination and the outcome will
           be assigned "failure ".

        -  A second echocolordoppler assessment performed on the first postoperative day (as per
           routine) The study will be conducted in accordance with the ethical principles deriving
           from the Helsinki Declaration and the current legislation on Observational Studies.

Study Type

Observational

Primary Outcome

technical success

Secondary Outcome

 minor complications

Condition

Aneurysm

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

320

Start Date

January 9, 2019

Completion Date

March 31, 2020

Primary Completion Date

March 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  adult patients aged ≥ 18 years, belonging to the Operative Unit of Vascular Surgery of
             the San Raffaele Hospital,

          -  patients candidates for endovascular treatment for thoracic, thoracoabdominal or
             abdominal aortic pathologies.

        Exclusion Criteria:

        - There are no criteria for exclusion of subjects from the study.

Gender

All

Ages

18 Years - N/A

Contacts

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Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT03484013

Organization ID

PEVAR-PRO/141/OSR

Responsible Party

Principal Investigator

Study Sponsor

IRCCS San Raffaele

Study Sponsor

, ,

Verification Date

May 2020