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
, ,
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