Lake Washington Vascular VenaSeal™ Post-Market Evaluation (WAVES) (WAVES)

March 14, 2018 updated by: Lake Washington Vascular

Lake Washington Vascular VenaSeal™ Post-Market Evaluation: WAVES

The VenaSeal Closure system offers an outpatient treatment option for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Bellevue, Washington, United States, 98004
        • Lake Washington Vascular, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Reflux in at least one target vein;
  • One or more of the following symptoms related to a TV: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling;
  • CEAP classification of C2 (if symptomatic) through C5;

Key Exclusion Criteria:

  • Current, regular use of systemic anticoagulation;
  • Previous or suspected deep vein thrombosis or pulmonary embolus, or active acute superficial thrombophlebitis, or thrombophlebitis migrans;
  • Previous treatment such as laser or radiofrequency ablation of venous disease in targeted vein segment;
  • Known hypercoagulable disorder;
  • Pregnant or breast feeding at enrollment;
  • Known sensitivity to cyanoacrylate adhesives;
  • Venous treatment in the contralateral limb within the last 30 days, or who require contralateral treatment within three months;
  • Planned to undergo additional ipsilateral treatments on the same leg within 3 months following treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Historical Control with Propensity Analysis
Device: SP-402 VenaSeal™ Closure System
A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..
Other Names:
  • VenaSeal™
Experimental: VenaSeal Treatment Arm
Device: SP-402 VenaSeal™ Closure System
A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..
Other Names:
  • VenaSeal™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.
Time Frame: 1 month
CC of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CC of the PTVS, as assessed by duplex ultrasound
Time Frame: 1 week and 3 months after treatment
1 week and 3 months after treatment
CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound
Time Frame: 1 month and 3 months after the index procedure
1 month and 3 months after the index procedure
Quality of life as measured by the venous clinical severity scores (rVCSS)
Time Frame: 1 and 3 months after treatment
1 and 3 months after treatment
Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ)
Time Frame: 1 and 3 months after treatment
1 and 3 months after treatment
Quality of life as measured by the EQ-5D
Time Frame: 1 and 3 months after treatment
1 and 3 months after treatment
Return to normal activities and return to work; day of procedure is day 0
Time Frame: 1 week, 1 month
1 week, 1 month
Need for adjunctive treatment
Time Frame: 3 months
Measured in case report form (yes or no, and if yes, the Investigator will specify what the adjunctive measure is).
3 months
Safety and adverse event for below the knee greater saphenous vein treatment
Time Frame: 1 week, 1 month, 3 months
1 week, 1 month, 3 months
Safety and adverse events for large diameter TVS defined as veins larger than 8 mm in diameter
Time Frame: 1 week, 1 month, 3 months
1 week, 1 month, 3 months
Patient satisfaction
Time Frame: 1 week, 1 month, 3 months
At selected visits, the subject will complete a brief questionnaire rating satisfaction with treatment provided and whether the subject would undergo the treatment again.
1 week, 1 month, 3 months
CC of TVS, expressed on a per-segment basis
Time Frame: 1 month and 3 months
1 month and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lake Washington Vascular

Collaborators

Syntactx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Actual)

March 16, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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