Endovascular Treatment of Aorto-iliac Occlusions

Iliac Artery Disease Clinical Trial

Official title:

Endovascular Treatment of Different Types of Aorto-iliac Occlusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824730
• Other study ID #: CCSerbia Vasc
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: September 1, 2018

Study information

• Verified date: January 2019
• Source: Clinical Centre of Serbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 1, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Institute for Cardiovascular Diseases Dedinje	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Centre of Serbia

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	Clinical success	During the follow-up period, the improvement of Rutherford classification 1 grade or more than 1 grade.	60 months
Secondary	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