Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2013-01-01
2018-09-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Endovascular occlusions group
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 who experienced an initial technical failure
18 Years
ALL
No
Sponsors
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Clinical Centre of Serbia
OTHER
Responsible Party
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Vladimir Cvetic
Principal Investigator
Principal Investigators
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Dragan Z Sagic, Prof
Role: PRINCIPAL_INVESTIGATOR
Institute for Cardiovascular Diseases Dedinje
Locations
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Clinical Center of Serbia
Belgrade, , Serbia
Institute for Cardiovascular Diseases Dedinje
Belgrade, , Serbia
Countries
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Other Identifiers
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CCSerbia Vasc
Identifier Type: -
Identifier Source: org_study_id