Varicose Veins, Venous Reflux
Conditions
Keywords
Venaseal, cyanoacrylate closure
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.
Interventions
DIAGNOSTIC_TESTUltrasound
Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.
Sponsors
Medtronic Vascular
Lake Washington Vascular
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
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). \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Closure of Target Vein(s) at 3 years after index treatment | 3 years post 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Severity via Varicose Vein Questionnaire (AVVQ) | 3 years post treatment | 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. |
| Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire | 3 years post treatment | 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). |
| Need for adjunctive treatments | 3 years post treatment | Either at the index procedure or at any point following the index procedure |
| Health care utilization | 3 years post treatment | Via chart review and patient questionnaire |
| Venous disease severity assessed via Venous Clinical Severity Score | 3 years post treatment | 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. |
Countries
United States
Contacts
Primary ContactKim D Glorieux, BS, BS, CCRC
Outcome results
None listed