Endovascular Treatment of Different Types of Aorto-iliac Occlusions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aorto-Iliac Occlusive Disease
- Sponsor
- Clinical Centre of Serbia
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Primary artery/stent patency rate
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Vladimir Cvetic
Principal Investigator
Clinical Centre of Serbia
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Primary assisted artery/stent patency rate(60 months)
- Clinical success(60 months)
- Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment(1 month)
- Secondary patency artery/stent rate(60 months)