blod flow post trombotic syndrome
Conditions
Interventions
Geko device versus IPCS or open fistula
Sponsors
Vaatchirurgie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Only patients that fulfill either a) or b) and c) are able to participate into this study: a) Patients that suffer from post-thrombotic obstruction, which are in need of a percutaneous intervention by stenting (will be considered as study percutaneous group 1). b) Patients that suffer from post-thrombotic obstruction whereby endophlebectomy and placement of an AVF has to be performed (will be considered as study hybrid group 2). c) Patients have to be minimally 18 years of age or older.
Exclusion criteria
Exclusion criteria: Peripheral arterial disease, comorbidities leading to impaired muscle function of either lower limb, co-morbidities affecting the circulatory system, history of deep venous surgery in either lower limb or groin, allergies to the plasters, pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint and parameter of this study is time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography (DUS) using its pulse wave Doppler function | — |
Secondary
| Measure | Time frame |
|---|---|
| Sex, age and body mass index will be obtained for demographic purposes. VAS score will be collected to evaluate the tolerability of the devices. Villalta score, Venous Clinical Severity Score, extent of post-thrombotic disease based on DUS and magnetic resonance venography, history of previous venous interventions, and CEAP score, will also be collected. | — |
Countries
Netherlands
Outcome results
None listed