Clinical trial NCT04146168: Lake Washington Vascular VenaSeal™ Post-Market Evaluation
Official title: Clinical and Patient-Centered Outcomes Three Years After Venaseal Treatment: Lake Washington Vascular VenaSeal Post Market Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicose Veins
Venous Reflux
Keywords: Venaseal
cyanoacrylate closure
Lead sponsor: Lake Washington Vascular
Sponsor class: OTHER
Collaborators: name: Medtronic Vascular
First posted: 2019-10-31
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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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Primary outcomes:
measure: Complete Closure of Target Vein(s) at 3 years after index treatment
timeFrame: 3 years post treatment
Secondary outcomes:
measure: Venous disease severity assessed via Venous Clinical Severity Score
timeFrame: 3 years post treatment
measure: Clinical Severity via Varicose Vein Questionnaire (AVVQ)
timeFrame: 3 years post treatment
measure: Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire
timeFrame: 3 years post treatment
measure: Need for adjunctive treatments
timeFrame: 3 years post treatment
measure: Health care utilization
timeFrame: 3 years post treatment
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Lake Washington Vascular
state: Washington
city: Issaquah
country: United States
facility: Lake Washington Vascular
state: Washington
city: Kirkland
country: United States
facility: Lake Washington Vascular
state: Washington
Study officials:
affiliation: Lake Washington Vascular, PLLC
name: Kathleen Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References: