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

Clinical and Patient-Centered Outcomes Three Years After Venaseal Treatment: Lake Washington Vascular VenaSeal Post Market Evaluation

New-WAVES Study seeks to expand understanding/results from prior study (NCT02585726). Assessing both clinical outcomes and patient satisfaction after treatment with Venaseal/Cyanoacrylate Adhesive Closure System

Study Overview

• Status: Unknown
• Conditions: Varicose Veins; Venous Reflux
• Intervention / Treatment: Diagnostic test: Ultrasound

Detailed Description

New WAVES is an investigator initiated protocol that will assess clinical outcomes and patient satisfaction after treatment with VenaSeal(TM)/ Cyanoacrylate Adhesive Closure System 3 years post-treatment. All patients treated from a multi-provider practice, whom meet protocol inclusion criteria, will be invited to consider participation in this study.

• Study Type: Observational
• Enrollment (Anticipated): 124

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bellevue, Washington, United States, 98004
      • Recruiting
      • Lake Washington Vascular
      • Contact: Kim Glorieux, BS, BS, CCRC; Phone Number: 425-453-1772; Email: kimg@lkwv.com
      • Sub-Investigator: Brian Ferris, MD
      • Sub-Investigator: Renee Minjarez, MD
      • Sub-Investigator: Elena Rinehardt, MD
    • Issaquah, Washington, United States, 98027
      • Recruiting
      • Lake Washington Vascular
      • Contact: Kim Glorieux, BS, BS, CCRC; Phone Number: 425-453-1772; Email: kimg@lkwv.com
      • Sub-Investigator: Brian Ferris, MD
      • Sub-Investigator: Renee Minjarez, MD
      • Sub-Investigator: Elena Rinehardt, MD
    • Kirkland, Washington, United States, 98034
      • Recruiting
      • Lake Washington Vascular
      • Contact: Kim Glorieux, BS, BS, CCRC; Phone Number: 425-453-1772; Email: kimg@lkwv.com
      • Sub-Investigator: Brian Ferris, MD
      • Sub-Investigator: Renee Minjarez, MD
      • Sub-Investigator: Elena Rinehardt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from the practice by identification of all patients treated with the Venaseal Closure System from October 2015 to December 31, 2016. This will include 50 prior subjects whom participated in the WAVES trial (ClinicalTrials.gov Identifier: NCT02585726), and up to 75 additional subjects whom also received the treatment with Venaseal but were not enrolled in the WAVES trial. All potential subjects for this study will have received treatment at Lake Washington Vascular, PLLC. Prior WAVES trial subjects initially enrolled will be approached with an introductory letter to be sent via e-mail or physical address. The correspondence will be sent to all potential study subjects explaining the purpose of the study and inviting them to participate. This correspondence will be followed up with a phone contact from study personnel.

Description

Inclusion Criteria:

1. Age ≥18 years; 2. Treatment of the great, small or accessory saphenous vein or any combination of saphenous veins with the Venaseal Closure System; 3. Treatment occurred at least 30 months prior to study; 4. Ability to understand the requirements of the study and to provide informed consent.

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Exclusion Criteria:

1. Subsequent treatment (such as laser or radiofrequency ablation) of venous disease in targeted vein segment after Venaseal closure; 2. Patients in whom index procedure information is unavailable; 3. Patients unwilling to undergo ultrasound evaluation and clinical examination of the previously treated limb; 4. Limbs that were treated in the VeClose trial (patients who participated in VeClose and later had contralateral limb treatment will be included).

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VenaSeal; Complete closure of previously treated veins will be assessed via ultrasound	Diagnostic test: Ultrasound; Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.; Other Names: Unilateral ultrasound of Limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Closure of Target Vein(s) at 3 years after index treatment	Complete closure is defined as Doppler Ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm.	3 years post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous disease severity assessed via Venous Clinical Severity Score	Assessed via the revised Venous Clinical Severity Score (rVCSS). The rVCSS is an Investigator assessment of the severity of venous reflux disease, assessing signs and symptoms such as pain, varicose veins, venous edema, skin pigmentation, induration, and inflammation.	3 years post treatment
Clinical Severity via Varicose Vein Questionnaire (AVVQ)	Assessed via Aberdeen Varicose Vein Questionnaire (AVVQ) is a disease specific 13 item questionnaire is used to assess the impact of varicose veins on the quality of life, such as pain caused by varicose veins, and the need to take pain medication.	3 years post treatment
Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire	Assessed via EQ-5D Questionnaire. The EQ-5D is a short generic quality of life survey that is commonly used outside of the United States for health technology assessments. The "health state today" question provides an overall assessment along a 20 cm visual analog scale (VAS) with a range from 0 ("worst imaginable health state") to 100 ("best imaginable health state").	3 years post treatment
Need for adjunctive treatments	Either at the index procedure or at any point following the index procedure	3 years post treatment
Health care utilization	Via chart review and patient questionnaire	3 years post treatment

Collaborators and Investigators

• Sponsor: Lake Washington Vascular
• Collaborators: Medtronic Vascular
• Investigators: Principal Investigator: Kathleen Gibson, MD, Lake Washington Vascular, PLLC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (ACTUAL): October 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Venaseal; cyanoacrylate closure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: 2019-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No