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| Name | Class |
|---|---|
| Clinical Centre of Serbia | OTHER |
| University of Padova | OTHER |
| University of Bari | OTHER |
| University of Trieste |
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This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II
Open surgery repair with Aortobifemoral Bypass (ABF) remains the gold standard revascularization technique in patients with lifestyle-limiting intermittent claudication (IC) and chronic limb-threatening ischemia due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type D lesions
The ABF procedure has proven safe, effective, and durable, particularly considering its high long-term patency rates (85%-90% at five years and 75%-80% at ten years) despite its significant peri-operative associated morbidity (1). On the other hand, endovascular treatment (EVT) offers an attractive alternative with durable results (four- or 5-year primary and secondary patency rates ranged from 60% to 86% and 80% to 98%, respectively), especially in less extensive AIOD, while also providing less perioperative morbidity, making it generally preferable for patients with more severe comorbid conditions.
Thus, surgical approaches to extensive AIOD have changed considerably over the last years, primarily due to increased EVT, particularly with the uncovered aortoiliac stenting (AIS). While TASC II provides an anatomical framework to compare therapeutic techniques, the advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies. It is attractive for patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to ABF
This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease | Chronic limb-threatening ischemia or claudicants due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type C and D lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortobifemoral bypass | Procedure | Open surgery with aortic and iliac reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Amputation | Amputation above the ankle | through study completion, an average of 3 years |
| Cardiovascular Death | Death from cardiovascular disease | through study completion, an average of 3 years |
| acute myorcardial infartion | According to the 4th definition of Myocardial infarction | through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Limb Events | Amputation above the ankle, arterial thrombosis of the limb, binary restenosis | through study completion, an average of 3 years |
| Major adverse cardiovascular events | acute myocardial infarction; acute heart faillure, cardiovascular death, coronary reintervention |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive care unit instay | Intensive care unit instay - days) | until 30 days |
| acute kidney injury (AKI) | AKI according to Riffle criteria | until 30 days |
Inclusion Criteria:
Patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with TransAtlantic Inter-Society Consensus (TASC II) type D classification(12).
Exclusion Criteria:
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Patients undergoing revascularization of the aorto-iliac sector for peripheral arterial disease at any of the center in study starting in January 2016 until December 2023.A consecutive sample will be prepared, containing all patients at the recruiting centers, fulfilling the following criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Universitário de São João, EPE | Porto | 4200-319 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20598474 | Background | Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg. 2010 Nov;52(5):1376-83. doi: 10.1016/j.jvs.2010.04.080. | |
| 28390920 | Background | Groot Jebbink E, Holewijn S, Slump CH, Lardenoije JW, Reijnen MMPJ. Systematic Review of Results of Kissing Stents in the Treatment of Aortoiliac Occlusive Disease. Ann Vasc Surg. 2017 Jul;42:328-336. doi: 10.1016/j.avsg.2017.01.009. Epub 2017 Apr 6. |
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The anonymity and confidentiality of participants will be safeguarded. The patient will be entered without any reference to their name. The participant number will correspond to the clinical information in a separate database, which will only be used for the proposed objective after supervision by the PI and Supervisor. For analysis purposes, the participant number will be deleted.
All information entered in the database will be constant in the clinical process.
The results may be published in a scientific journal and/or congress. Rules of Ethical Conduct and Good Practices will be observed to ensure compliance with the precepts of the Declaration of Helsinki, the Convention on Human Rights and Biomedicine, the guidelines of the Council for International Organizations of Medical Sciences and the Guide to Good Clinical Practices.
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| OTHER |
| University of Nis | OTHER |
| Centro Hospitalar de Vila Nova de Gaia/Espinho | OTHER |
| Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro | OTHER |
| Centro Hospitalar do Porto | OTHER |
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| aortoiliac stenting | Procedure | Endovascular reconstruction of aortic and iliac arterial obstruction: Balloon angioplasty may be performed initially to dilate the narrowed segment of the iliac artery. Subsequently, a stent delivery system is advanced over the wire and positioned across the lesion. The stent is deployed under fluoroscopic guidance to expand and scaffold the diseased artery, restoring blood flow. Vascular - iliac dedicated Stent - any brand |
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| through study completion, an average of 3 years |
| Death | Diagnosed by a physician | through study completion, an average of 3 years |
| Faculdade de Medicina da Universidade do Porto | Porto | 4200-319 | Portugal |
| ID | Term |
|---|---|
| D007925 | Leriche Syndrome |
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001157 | Arterial Occlusive Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
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