Endovascular Treatment of Aorto-iliac Occlusions

Completed

• Conditions: Iliac Artery Occlusion; Iliac Artery Disease; Aorto-Iliac Occlusive Disease
• Interventions: Device: Stenting of the Common and/or External Iliac Arteries

• Registration Number: NCT03824730
• Lead Sponsor: Clinical Centre of Serbia

Brief 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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2017-11-01
• Study Completion: 2018-09-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endovascular occlusions group	Stenting of the Common and/or External Iliac Arteries	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

Primary Outcome Measures

Name	Time	Method
Primary artery/stent patency rate	60 Months	Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Institute for Cardiovascular Diseases Dedinje; 🇷🇸 Belgrade, Serbia