AneurysmPEVAR-PRONCT03484013
Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO)
An observational study of Aneurysm and Aneurysm Abdominal, run by IRCCS San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Aneurysm Abdominal, Aneurysm Thoracic
- How many people
- 320 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- There are no criteria for exclusion of subjects from the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Medical subject headings
- Aneurysm, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Aortic Aneurysm, Thoracoabdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the surgery
Secondary outcomes (1)
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)
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start9 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bertoglio Luca, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484013
- Sponsor's protocol ID
- PEVAR-PRO/141/OSR
- Acronym
- PEVAR-PRO
- Status last verified
- May 2020
- First submitted
- 12 Dec 2017
- Last updated
- 14 May 2020
- Results posted
- No
Publications
Melloni A, Grandi A, Spelta S, Salvati S, Loschi D, Lembo R, Melissano G, Chiesa R, Bertoglio L. Outcomes of routine use of percutaneous access with large-bore introducer sheaths (>21F outer diameter) during endovascular aneurysm repair. J Vasc Surg. 2021 Jan;73(1):81-91. doi: 10.1016/j.jvs.2020.04.504. Epub 2020 May 19.
PubMed 32442603
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO)
- ClinicalTrials.gov ID
- NCT03484013
- Acronym / sponsor ID
- PEVAR-PRO / PEVAR-PRO/141/OSR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no criteria for exclusion of subjects from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
technical success
Time frame: during the surgery
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
1 secondary outcome
minor complications
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Derived from this study: PubMed 32442603Melloni A, Grandi A, Spelta S, Salvati S, Loschi D, Lembo R, Melissano G, Chiesa R, Bertoglio L. Outcomes of routine use of percutaneous access with large-bore introducer sheaths (>21F outer diameter) during endovascular aneurysm repair. J Vasc Surg. 2021 Jan;73(1):81-91. doi: 10.1016/j.jvs.2020.04.504. Epub 2020 May 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm and Aneurysm Abdominal, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical success (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.