Endovascular Treatment of Aorto-iliac Occlusions

Clinical Centre of Serbia

Status: Completed

Conditions: Aorto-Iliac Occlusive Disease; Iliac Artery Occlusion; Iliac Artery Disease

Treatments: Device: Stenting of the Common and/or External Iliac Arteries

Study type: Observational

Funder types: Other

Identifiers

NCT03824730

CCSerbia Vasc

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Endovascular occlusions group

Description:

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

Treatment:

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