NCT03824730

Endovascular Treatment of Aorto-iliac Occlusions

Endovascular Treatment of Different Types of Aorto-iliac Occlusions

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Clinical Centre of Serbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Aorto-Iliac Occlusive Disease
• Iliac Artery Occlusion
• Iliac Artery Disease

Interventions

Type	Name	Description
DEVICE	Stenting of the Common and/or External Iliac Arteries	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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-11-01
• Completion: 2018-09-01
• First posted: 2019-01-31
• Last updated: 2019-01-31

Locations

2 sites across 1 country: Serbia