Lake Washington Vascular VenaSeal™ Post-Market Evaluation

NCT04146168 | Unknown

• 1 other identifier: 2019-02
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Varicose Veins; Venous Reflux

Keywords

Venaseal; cyanoacrylate closure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Venous disease severity assessed via Venous Clinical Severity Score

  3 years post treatment

• Clinical Severity via Varicose Vein Questionnaire (AVVQ)

  3 years post treatment

• Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire

  3 years post treatment

• Need for adjunctive treatments

  3 years post treatment

• Health care utilization

  3 years post treatment

Study Arms (1)

VenaSeal

Complete closure of previously treated veins will be assessed via ultrasound

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.

Also known as: Unilateral ultrasound of Limb

VenaSeal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Lake Washington Vascular: lead
• Medtronic Vascular: collaborator

Study Sites (3)

Lake Washington Vascular

Bellevue, Washington, 98004, United States

RECRUITING

Lake Washington Vascular

Issaquah, Washington, 98027, United States

RECRUITING

Lake Washington Vascular

Kirkland, Washington, 98034, United States

RECRUITING

MeSH Terms

Conditions

Varicose Veins

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kathleen Gibson, MD

  Lake Washington Vascular, PLLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim D Glorieux, BS, BS, CCRC

CONTACT

425-453-1772; kimg@lkwv.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: November 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)