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This observational study is to evaluate performance and safety of the DUO Venous Stent for the treatment of obstructions of the iliac vein.
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| Measure | Description | Time Frame |
|---|---|---|
| Primary 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency rates | 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 |
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Inclusion Criteria:
Patient is willing and able to provide inform consent
Patients must be ≥ 18 years of age at the time of consent
Estimated life expectancy ≥ 12 months.
Body mass index (BMI) <35
Patients to whom the DUO Venous Stent can be implanted according to the IFU (this includes acute iliac deep vein thrombosis (DVT), post-thrombotic syndrome, non-thrombotic iliac vein compression (e.g. May-Thurner), non-thrombotic iliac vein compression (e.g. compression from ecstatic or tortuous iliac arteries))
As per IFU, clinically significant symptomatic venous outflow obstruction in the iliac venous segment, associated by at least one of the following:
Subject is willing and able to comply with physician's recommendation for compression therapy -
Exclusion Criteria:
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Subjects with symptomatic obstruction of the iliac vein
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Lichtenberg, MD | Contact | +49 02923 952 242 | 201 | M.Lichtenberg@klinikum-hochsauerland.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular center of Klinikum Hochsauerland GmbH | Recruiting | Arnsberg | 59759 | Germany |
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| 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). | 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 | 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). | 30 Days, 6, 12 and 24 month |
| Device or procedure-related adverse events | 30 Days, 6, 12 and 24 month |
| Serious adverse events | 30 Days, 6, 12 and 24 month |