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

Aneurysm Clinical Trial

— PEVAR-PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484013
• Other study ID #: PEVAR-PRO/141/OSR
• Status: Completed
• Start date: January 9, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Abdominal
• Aneurysm Thoracic
• Aneurysm, Thoracoabdominal Aortic
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	technical success	Use of femoral artery access in endovascular repair of aortic aneurysm (time frame between 2015 and 2020); Endovascular procedure: TEVAR - EVAR - B/FEVAR; Side of femoral access: right- left; Employment of downsizing on the femoral access: yes - no, as reported on patients' charts and operative report; Size of percutaneous access sheath employed measured in French - Fr; Number of percutaneous access vessel closure devices employed; Access closure specific outcome: success - failure, as reported on patients' charts and operative report; Cause of failure: hemorrhagic - occlusive, as reported on patients' charts and operative report	during the surgery
Secondary	minor complications	Femoral access vascular anatomy and patient's characteristics (time frame between 2015 and 2020): Previous surgical access to ipsilateral femoral artery: yes - no; Previous deployment of percutaneous vascular closure devices to ipsilateral femoral artery: yes - no; Diameter of femoral artery measured in millimiters (mm); Presence of calcification at access site: less or equal to1/3 of circumference - between 1/3 (excluded) and 2/3 (included) - more than 2/3 as measured on preoperative CT scan; Localization of calcification: anterior - posterior - circumferential - lateral; Body mass index reported as bare number defined as weight (kg)/height^2(m^2)	30 days after surgery