Skip to main content
OpenTrials
Completed

NCT Number: NCT03824730

Endovascular Treatment of Aorto-iliac Occlusions

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aorto-Iliac Occlusive Disease Bites and Stings Chemically-Induced Disorders Iliac Artery Disease Iliac Artery Occlusion Poisoning Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Center of Serbia, Belgrade, Serbia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stenting of the Common and/or External Iliac Arteries

Device

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.

Other names: Percutaneous Transluminal Angioplasty, stent implantation

Primary outcomes

  1. Primary artery/stent patency rate

    Time frame: 60 Months

    Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation.

Secondary outcomes

  1. Primary assisted artery/stent patency rate

    Time frame: 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.

  2. Secondary patency artery/stent rate

    Time frame: 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

  3. Clinical success

    Time frame: 60 months

    During the follow-up period, the improvement of Rutherford classification 1 grade or more than 1 grade.

  4. Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment

    Time frame: 1 month

    Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire.

Sponsors and collaborators

Lead sponsor

Clinical Centre of Serbia

Other

Registry information

Official study title

Endovascular Treatment of Different Types of Aorto-iliac Occlusions

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jan 31, 2019
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.