Lake Washington Vascular VenaSeal™ Post-Market Evaluation

Varicose Veins Clinical Trial

— New-WAVES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04146168
• Other study ID #: 2019-02
• Status: Recruiting
• Start date: November 2019
• Est. completion date: March 2020

Study information

• Verified date: October 2019
• Source: Lake Washington Vascular
• Contact: Kim D Glorieux, BS, BS, CCRC
• Phone: 425-453-1772
• Email: kimg[@]lkwv.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: March 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Varicose Veins
• Venous Reflux

Intervention

Diagnostic Test:
• Ultrasound
Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.

Locations

Country	Name	City	State
United States	Lake Washington Vascular	Bellevue	Washington
United States	Lake Washington Vascular	Issaquah	Washington
United States	Lake Washington Vascular	Kirkland	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Lake Washington Vascular	Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Need for adjunctive treatments	Either at the index procedure or at any point following the index procedure	3 years post treatment
Secondary	Health care utilization	Via chart review and patient questionnaire	3 years post treatment