An observational study in Aneurysm, Aneurysm Abdominal and Aneurysm Thoracic, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-14.
Sponsored by IRCCS San Raffaele · Observational
Among 13 studies in Aortic Aneurysm, Thoracoabdominal with a site in Italy — 4 open to participants now, 6 under way, none of them phase 3. Aortic Aneurysm, Thoracoabdominal · Italy.
Among the 13 studies in Aortic Aneurysm, Thoracoabdominal with a site in Italy, this one is the 4th largest by enrollment of the 11 observational ones that give a count, is one of 3 that started in 2019, is one of 11 observational ones, and was the 3rd registered.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
Browse Aortic Aneurysm, Thoracoabdominal studies →4 of the 13 studies in Aortic Aneurysm, Thoracoabdominal with a site in Italy are open now. Recruiting first, the newest first:
Rede Optimus Hospitalar SA · Sites in Italy, Germany, Switzerland
Ages 18+
University Hospital Padova · Sites in Italy
Ages 18–100
Cook Research Incorporated · Sites in Italy, Denmark, France and 3 more countries
University Hospital Padova · Sites in Italy
Ages 18–100
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 25 Aortic Aneurysm, Thoracoabdominal studies recruiting now, 18 (72%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes.
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13 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 3 started in 2019.
This study's enrollment of 320 is above the median of 100 across 20 observational studies indexed under Aortic Aneurysm, Thoracoabdominal.
Median enrollment 295 across the 2 interventional studies, 100 across the 11 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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2 of 13 have an industry lead sponsor. The 8 most frequent:
IRCCS San Raffaele is the lead sponsor of 454 studies on the registry; 235 are open to participants now.
IRCCS San Raffaele has 4 studies filed under Aortic Aneurysm, Thoracoabdominal — fewer than ten, so there is no comparison to draw.
1 of the studies in Aortic Aneurysm, Thoracoabdominal with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05896397Cook Research IncorporatedEuropean Aortic Data Collection Project | 2027-01 |
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Among the 13 studies in Aortic Aneurysm, Thoracoabdominal with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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:
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's enrollment of 320 is above the median of 100 across 20 observational studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →IRCCS San Raffaele is the lead sponsor of 454 studies on the registry; 235 are open to participants now.
Compared within Aortic Aneurysm, Thoracoabdominal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aneurysm. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Time frame: during the surgery
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)
Time frame: 30 days after surgery
Ran from Jan 2019 to primary completion in Mar 2020, 14 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Aortic Aneurysm, Thoracoabdominal →