Iliac Artery Disease Clinical Trial
Official title:
Endovascular Treatment of Different Types of Aorto-iliac Occlusions
Verified date | January 2019 |
Source | Clinical Centre of Serbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study compares early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions.
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 |
Country | Name | City | State |
---|---|---|---|
Serbia | Clinical Center of Serbia | Belgrade | |
Serbia | Institute for Cardiovascular Diseases Dedinje | Belgrade |
Lead Sponsor | Collaborator |
---|---|
Clinical Centre of Serbia |
Serbia,
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 |
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