This observational study is to evaluate performance and safety of the DUO Venous Stent for the treatment of obstructions of the iliac vein.
Study Type
OBSERVATIONAL
Enrollment
20
Vascular center of Klinikum Hochsauerland GmbH
Arnsberg, Germany
RECRUITINGPrimary patency rate at month 12
The primary patency rate is defined as the percentage of stented target lesions with primary treatment success and without the occurrence of thrombosis of the treated lesion or any re-intervention (surgical interventions on the target vessel) to restore or maintain flow within the treated lesion
Time frame: 12 months
Primary patency rates
Time frame: 30 Days, 6 and 24 months
Secondary patency rates
Percentage of patients with primary treatment success and without occurrence of permanent loss of flow in the treated segment, irrespective of any reintervention
Time frame: 30 Days, 6, 12 and 24 months
Revised Venous Clinical Severity Score (VCSS)
The score includes 10 clinical parameters (pain, varicose veins, venous edema, skin hyperpigmentation, inflammation, induration, number of ulcers, durations of ulcers, size of ulcers, and compliance with compression therapy). Each item is graded from zero to three depending on severity (None = 0, Mild = 1, Moderate = 2, Severe = 3).
Time frame: 30 Days 6, 12 and 24 month
Clinical Etiological Anatomical Pathophysiological Classification score (CEAP)
The score for the clinical condition of the chronic venous insufficiency (C0 to C6) will be evaluated whereas C0 is representing the best and C6 the worst condition
Time frame: 30 Days, 6, 12 and 24 months
Villalta score
The score includes five symptoms (pain, cramps, heaviness, paresthesia, pruritus) and six clinical signs (pretibial edema, skin induration, hyperpigmentation, redness, venous ectasia, pain on calf compression).Each item is graded from zero (not present)to three (severe).
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Time frame: 30 Days, 6, 12 and 24 month
Device or procedure-related adverse events
Time frame: 30 Days, 6, 12 and 24 month
Serious adverse events
Time frame: 30 Days, 6, 12 and 24 month