Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis
Phase 4
- Conditions
- Deep Vein Thrombosis
- Registration Number
- NCT00640731
- Lead Sponsor
- OmniSonics Medical Technologies, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- DVT confirmed by venographic and ultrasound imaging, which has been symptomatic for a maximum of 14 days, or diagnosed within past 14 days defined as either first episode (no prior history in affected segment), or recurrent episode.
- Written informed consent
- Agreement to comply with follow up requirements
Exclusion Criteria
- Known R-L shunt, pulmonary A-V malformation
- Excessive tortuosity and/or sharp angulation in target treatment zone
- Isolated calf vein thrombosis
- Isolated DVT in veins peripheral to axillary vein
- Thrombus in peripheral vessel smaller than 5 mm
- Target treatment zone cannot be adequately accessed within the 100 cm working length of device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System Post-Index procedure
- Secondary Outcome Measures
Name Time Method Death, clinically detectable PE, significant vessel damage in target treatment area through 6 months post-index procedure Restoration and maintenance of antegrade in-line flow in target treatment area through 6 months post-index procedure QOL SF-36 through 6 months post-index procedure Incidence of clinically significant hemolysis Prior to discharge