NCT00640731

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 21, 2008

Status Verified

March 1, 2008

Enrollment Period

4 months

First QC Date

March 17, 2008

Last Update Submit

March 20, 2008

Conditions

Deep Vein Thrombosis

Keywords

DVTPeripheral Vascular DiseaseVenous ThrombosisDeep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Interventions

OmniWave Endovascular SystemDEVICE

Treatment with mechanical thrombolysis/thrombectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous ThrombosisPeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • John Aruny, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 21, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 21, 2008

Record last verified: 2008-03