- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03484013
Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO) (PEVAR-PRO)
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Milano, Italy, 20132
- San Raffaele Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
a sample of 320 subjects will be analyzed (considering the cases treated in the period: October 2015 - 31 december 2019).
The analysis of the retrospective data, will be based on the consultation of the archive of the individual treated patients, present on software platform belonging to the San Raffaele Hospital Information System) as well as the medical records.
An informatic database will be set up for the exclusive use of investigators. The data will be analyzed subsequently through the application of descriptive and inferential statistics techniques.
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
technical success
Time Frame: during the surgery
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Use of femoral artery access in endovascular repair of aortic aneurysm (time frame between 2015 and 2020)
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during the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minor complications
Time Frame: 30 days after surgery
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Femoral access vascular anatomy and patient's characteristics (time frame between 2015 and 2020):
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30 days after surgery
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEVAR-PRO/141/OSR
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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