Skip to main content
OpenTrials
Completed

NCT Number: NCT02585726

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Reflux Cardiovascular Diseases Varicose Veins Vascular Diseases Venous Insufficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lake Washington Vascular, PLLC

Bellevue, Washington, 98004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SP-402 VenaSeal™ Closure System

Device

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™

Primary outcomes

  1. 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.

Secondary outcomes

  1. CC of the PTVS, as assessed by duplex ultrasound

    Time frame: 1 week and 3 months after treatment

  2. 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

  3. Quality of life as measured by the venous clinical severity scores (rVCSS)

    Time frame: 1 and 3 months after treatment

  4. Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ)

    Time frame: 1 and 3 months after treatment

  5. Quality of life as measured by the EQ-5D

    Time frame: 1 and 3 months after treatment

  6. Return to normal activities and return to work; day of procedure is day 0

    Time frame: 1 week, 1 month

  7. 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).

  8. Safety and adverse event for below the knee greater saphenous vein treatment

    Time frame: 1 week, 1 month, 3 months

  9. 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

  10. 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.

  11. CC of TVS, expressed on a per-segment basis

    Time frame: 1 month and 3 months

Sponsors and collaborators

Lead sponsor

Lake Washington Vascular

Other

Collaborators

  • Syntactx

Registry information

Official study title

Lake Washington Vascular VenaSeal™ Post-Market Evaluation: WAVES

Acronym: WAVES

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 23, 2015
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.