Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study
BackgroundSince 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a seali...
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JMIR Publications
2022-07-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/7/e36995 |
| _version_ | 1797734935266590720 |
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| author | Gianmarco de Donato Edoardo Pasqui Pasqualino Sirignano Francesco Talarico Giancarlo Palasciano Maurizio Taurino |
| author_facet | Gianmarco de Donato Edoardo Pasqui Pasqualino Sirignano Francesco Talarico Giancarlo Palasciano Maurizio Taurino |
| author_sort | Gianmarco de Donato |
| collection | DOAJ |
| description |
BackgroundSince 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval.
ObjectiveThis registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience.
MethodsAll consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients’ baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint.
ResultsThe study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups.
ConclusionsThe results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label.
Trial RegistrationClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892
International Registered Report Identifier (IRRID)PRR1-10.2196/36995 |
| first_indexed | 2024-03-12T12:51:18Z |
| format | Article |
| id | doaj.art-897417f8ff2648ac95777909f34f1017 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:51:18Z |
| publishDate | 2022-07-01 |
| publisher | JMIR Publications |
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| spelling | doaj.art-897417f8ff2648ac95777909f34f10172023-08-28T22:43:04ZengJMIR PublicationsJMIR Research Protocols1929-07482022-07-01117e3699510.2196/36995Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) StudyGianmarco de Donatohttps://orcid.org/0000-0003-2451-8501Edoardo Pasquihttps://orcid.org/0000-0001-6619-0159Pasqualino Sirignanohttps://orcid.org/0000-0002-1312-1915Francesco Talaricohttps://orcid.org/0000-0002-7866-366XGiancarlo Palascianohttps://orcid.org/0000-0003-3421-1669Maurizio Taurinohttps://orcid.org/0000-0001-5853-9410 BackgroundSince 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. ObjectiveThis registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. MethodsAll consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients’ baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. ResultsThe study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. ConclusionsThe results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label. Trial RegistrationClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892 International Registered Report Identifier (IRRID)PRR1-10.2196/36995https://www.researchprotocols.org/2022/7/e36995 |
| spellingShingle | Gianmarco de Donato Edoardo Pasqui Pasqualino Sirignano Francesco Talarico Giancarlo Palasciano Maurizio Taurino Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study JMIR Research Protocols |
| title | Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study |
| title_full | Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study |
| title_fullStr | Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study |
| title_full_unstemmed | Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study |
| title_short | Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study |
| title_sort | endovascular abdominal aortic aneurysm repair with ovation alto stent graft protocol for the altair alto endograft italian registry study |
| url | https://www.researchprotocols.org/2022/7/e36995 |
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