Clinical trial NCT03824730: Endovascular Treatment of Aorto-iliac Occlusions
Official title: Endovascular Treatment of Different Types of Aorto-iliac Occlusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aorto-Iliac Occlusive Disease
Iliac Artery Occlusion
Iliac Artery Disease
Keywords: endovascular
stent
aorto-iliac
occlusions
iliac
Lead sponsor: Clinical Centre of Serbia
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with endovascular stent due to aorto-iliac occlusions

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.

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

Primary outcomes:
measure: Primary artery/stent patency rate
timeFrame: 60 Months
Secondary outcomes:
measure: Primary assisted artery/stent patency rate
timeFrame: 60 months
measure: Secondary patency artery/stent rate
timeFrame: 60 months
measure: Clinical success
timeFrame: 60 months
measure: Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment
timeFrame: 1 month
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular Diseases Dedinje
Study officials:
affiliation: Institute for Cardiovascular Diseases Dedinje
name: Dragan Z Sagic, Prof
role: PRINCIPAL_INVESTIGATOR
References: