Endovascular Treatment of Aorto-iliac Occlusions

Study Overview
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Brief Summary
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This study compares early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions.

Detailed Description
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Endovascular treatment has been increasingly applied as a therapeutic option for aorto-iliac occlusive disease during the last decade, becoming the first-line treatment for many of the Trans-Atlantic Inter-Society Consensus document II (TASC II) categories. TASC II document in 2007 stated endovascular treatment as the method of choice up to type B occlusions and surgery for low-risk patients with type C and D occlusions, emphasizing that the patient's comorbidities as well as the operator's long-term success rates should be included in the decision-making process. Revision of TASC II document in 2015 is suggesting that the preferred revascularization method should be based on each vascular center's competence and experience with the anatomic complexity, considering patient comorbidity and overall prognosis, supporting the endovascular-first approach in all 4 different kinds of lesions in highly experienced centers. These changes over time are based on expert opinions derived from smaller studies from high volume centers, and that they reflect both the widespread gain of endovascular experience and technical developments over the last 2 decades, leading to a rising number of centers providing an endovascular-first approach even in complex TASC C and D occlusions. Rationale for offering endovascular-first option to patient with complex lesion would be low risk of complication and long-term patency. Our intention is to compare early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions in two Serbian vascular centres.

Official Title
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Endovascular Treatment of Different Types of Aorto-iliac Occlusions

Conditions
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Aorto-Iliac Occlusive Disease, Iliac Artery Occlusion, Iliac Artery Disease

Intervention / Treatment
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* Device: Stenting of the Common and/or External Iliac Arteries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has aorto-iliac occlusions type B, C & D according to TASC-II classification Patient suffers from severe claudication (Rutherford 3) or critical limb ischemia (Rutherford 4 and 5) Patients fulfilling criteria for endovascular treatment of aorto-iliac occlusion according to criteria of the participating centres. Exclusion Criteria: Patients with associated abdominal or iliac aneurysm, restenotic lesions, acute thrombi or dissections, Patients who experienced an initial technical failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovascular occlusions group<br>Group of patients with aorto-iliac occlusive disease (TASC B, C, D) in whom stenting of the Common and/or External Iliac Arteries were performed | Device: Stenting of the Common and/or External Iliac Arteries<br>* Stenting of the Common and/or External Iliac Arteries was performed in the angiographic suite. Under local anesthesia, arterial access was obtained through standard percutaneous puncture of the common femoral artery, brachial approach, or simultaneous brachial and femoral approach. Iliac lesion crossing was achieved through intraluminal or subintimal manner depending on the behavior of the lesion intraoperatively. Predilatation of the occlusion before stent deployment was performed at the discretion of the operator. Balloon-expandable stents were used for proximal, ostial lesions, whereas self-expanding stents were deployed in all other lesions. Both stents were used in long lesions involving heavily calcified common iliac arteries.<br>* Other names: stent implantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary artery/stent patency rate | Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation. | 60 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary assisted artery/stent patency rate | Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (>70%) at any time post-procedure. | 60 months | 
| Secondary patency artery/stent rate | Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at any time post-procedure | 60 months | 
| Clinical success | During the follow-up period, the improvement of Rutherford classification 1 grade or more than 1 grade. | 60 months | 
| Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment | Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endovascular, stent, aorto-iliac, occlusions, iliac