This is a prospective, multi-center single arm registry to assess the use of the OmniWave Endovascular System in subjects presenting with either lower or upper extremity acute (symptoms have been present for greater than or equal to 14 days) DVT.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Treatment with mechanical thrombolysis/thrombectomy
Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System
Time frame: Post-Index procedure
Death, clinically detectable PE, significant vessel damage in target treatment area
Time frame: through 6 months post-index procedure
Restoration and maintenance of antegrade in-line flow in target treatment area
Time frame: through 6 months post-index procedure
QOL SF-36
Time frame: through 6 months post-index procedure
Incidence of clinically significant hemolysis
Time frame: Prior to discharge
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