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Venous RefluxNCT03820947

VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

A study testing VenaSeal™ System, Endothermal Ablation (ETA) and Surgical Stripping in people with Venous Reflux, run by Medtronic Endovascular at 32 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Reflux
What is being tested?
VenaSeal™ System, Endothermal Ablation (ETA) and Surgical Stripping
Could I receive a placebo?
No, everyone receives an active treatment
How many people
506 participants
Where
32 sitesin 10 countries
Study dates
5 Feb 2020to 10 Nov 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is ≥18 years of age
  • Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by Duplex Ultrasound (DUS)
  • Eligibility for treatment:
  • VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA
  • VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping
  • VLU Study: patients should be eligible for treatment with the VenaSeal™ system
Show all 10Show fewer
  • Treatable refluxing segment of target vein(s) 10 cm in length or longer
  • Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing
  • Patient is willing and capable of complying with specified follow-up evaluations at the specified times
  • Patient has an ability to understand the requirements of the study and to provide informed consent

Who cannot join

  • Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity
  • Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care
  • Patient has abnormal pulse exam or Ankle-Brachial Index (ABI) <0.8
  • Patient has acute superficial thrombophlebitis
  • Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure
  • Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)
Show all 17Show fewer
  • Instructions for Use (IFU) contraindications:
  • VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s)
  • VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s)
  • VLU Study: Patient has VenaSeal™ system IFU contraindication(s)
  • Patient is non-ambulatory
  • Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure
  • Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures
  • Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study
  • Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.
  • VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory
  • VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)

Trial locations and contacts

32 sites in 10 countries.

32 sites in 10 countries

United States12 sites

  • Lake Washington Vascular

    Bellevue, Washington, 98004-4623

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Vascular Care Connecticut

    Darien, Connecticut, 06820

  • Valley Vascular Surgical Associates

    Fresno, California, 93701

  • Orion Medical

    Houston, Texas, 77034

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10024

  • Yavapai Regional Medical Center

    Prescott Valley, Arizona, 86314-2255

  • PIMA Heart and Vascular

    Tucson, Arizona, 85718

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007-2113

  • Vascular Care Group

    Wellesley, Massachusetts, 02482

Other trials in United States

South Korea4 sites

  • Seoul National University Hospital

    Seoul, 110-744

  • Seoul Saint Mary's Hospital

    Seoul, 137-701

  • Konkuk University Medical Center

    Seoul, 143-729

  • Gangnam Severance Hospital

    Seoul

Other trials in South Korea

United Kingdom4 sites

  • Bedfordshire Hospitals NHS Foundation Trust

    Bedford, MK42 9DJ

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • West London Vascular and Interventional Centre

    Harrow, HA1 3UJ

  • Imperial College Healthcare NHS Trust - Charing Cross Hospital

    London, W12 0HS

Other trials in United Kingdom

France3 sites

  • CHU Dijon Bourgogne

    Dijon, DIjon Cedex, 21079

  • Clinique du Parc

    Lyon, 69006

  • Clinique Pasteur

    Toulouse

Other trials in France

Australia2 sites

  • Sunshine Coast University Hospital

    Birtinya, 4575

  • Wollongong Hospital

    Wollongong

Other trials in Australia

Italy2 sites

  • Ospedale Fatebenefratelli e Oftalmico

    Milan, 20121

  • Azienda Ospedaliera di Padova Ospendale Sant' Antonio

    Padova, 35127

Other trials in Italy

Spain2 sites

  • Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)

    Granada, 18016

  • Sanitas Hospital Universitario La Zarzuela

    Madrid, 28023

Other trials in Spain

Canada1 site

  • East Toronto Vascular Clinic

    Toronto, Ontario, M4L 3Y3

Other trials in Canada

Germany1 site

  • Praxis fur Innere Medizin und Gefäβkrankheiten

    Halle, 06108

Other trials in Germany

Netherlands1 site

  • Rijnstate - Locatie Arnhem

    Arnhem, 6815

Other trials in Netherlands

About this study

Official title: Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

Read the detailed description

The study is designed with two randomized studies and one single arm study.

Two randomized studies are for CEAP 2-5 subjects:

  1. VenaSeal vs. Surgical Stripping Study (outside of the United States only)
  2. VenaSeal vs. ETA Study

The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):

  1. VLU Study
Conditions
Venous Reflux
Being tested
VenaSeal™ System, Endothermal Ablation (ETA), Surgical Stripping
Keywords
Venous reflux, Venous leg ulcer, Varicose Veins, Chronic Venous Insufficiency, VenaSeal, Endothermal Ablation, Surgical Stripping, Radiofrequency Ablation, Laser Ablation, Great Saphenous Vein (GSV), Small Saphenous Vein (SSV), Anterior Accessory Saphenous Vein, Venous Reflux Disease (VRD)
Medical subject headings
Varicose Ulcer, Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenaSeal™ SystemDevice

    The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

  • Endothermal Ablation (ETA)Device

    Also called Endovenous laser ablation (EVLA), Radiofrequency ablation (RFA)

    ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.

    Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

  • Surgical StrippingProcedure or surgery

    Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Study groups in NCT03820947
Study groupRoleWhat they receive
Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): VenaSeal™ SystemExperimentalCEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
Receives: Device: VenaSeal™ System
Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): ETAActive comparatorCEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
Receives: Device: Endothermal Ablation (ETA)
Randomized study VenaSeal™ System versus Surgical Stripping: VenaSeal™ SystemExperimentalCEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
Receives: Device: VenaSeal™ System
Randomized study VenaSeal™ System versus Surgical Stripping: Surgical StrippingActive comparatorCEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
Receives: Procedure: Surgical Stripping
Single arm Venous Leg Ulcer (VLU) Study: VenaSeal™ SystemExperimentalCEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System
Receives: Device: VenaSeal™ System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe).

    Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

    Measured: 30 days

  2. Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe).

    Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

    Measured: 30 days

  3. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs).

    Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

    Measured: 30 days

  4. Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs).

    Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

    Measured: 30 days

  5. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.

    Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

    Measured: Post Index procedure, on the day of the procedure immediately following treatment

  6. Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.

    Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

    Measured: Post Index procedure, on the day of the procedure immediately following treatment

  7. Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months.

    Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months.

    Measured: 12 months

Secondary outcomes (67)

  1. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

    Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

    Measured: 6 months

  2. Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

    Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

    Measured: 6 months

  3. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

    Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

    Measured: 6 months

  4. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

    Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

    Measured: 30 days

  5. Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

    Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

    Measured: 30 days

  6. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

    Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

    Measured: 30 days

  7. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.

    For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure at 30 days and 12, 24, 36, 48 and 60 months.

    Measured: 30 days and 12, 24, 36, 48 and 60 months

  8. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months.

    Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.

    Measured: 30 days, 12 months

  9. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.

    For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 12 months, 24 months, 36 months, 48 months and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure tat 30 days, 12 months, 24 months, 36 months, 48 months and 60 months

    Measured: 30 days, 12 months, 24 months, 36 months, 48 months and 60 months

  10. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.

    For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, and 6, 12, 24, 36, 48 and 60 months.

    Measured: 30 days, and 6, 12, 24, 36, 48 and 60 months

  11. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months.

    Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.

    Measured: 30 days, 6, 12 months

  12. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.

    For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure at 30 days, and 6, 12, 24, 36, 48 and 60 months.

    Measured: 30 days, and 6, 12, 24, 36, 48 and 60 months.

  13. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

    For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Measured: Post Index procedure, on the day of the procedure immediately following treatment

  14. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

    Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.

    Measured: Post Index procedure, on the day of the procedure immediately following treatment

  15. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

    For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Measured: Post Index procedure, on the day of the procedure immediately following treatment

  16. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit.

    Measured: 12 months

  17. Randomized Study VenaSeal™ System Versus Endothermal Ablation: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit.

    Measured: 60 months

  18. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months.

    As measured by the time between the index procedure and the first reintervention procedure.

    Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.

    Measured: 12 months

  19. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

    Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.

    Measured: 12 months

  20. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

    Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

    Measured: 12 months

  21. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

    Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

    Measured: 12 months

  22. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months.

    Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).

    Measured: 12 months

  23. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

    Measured: 12 months

  24. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

    Measured: 12 months

  25. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

    Measured: 12 months

  26. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.

    Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.

    Measured: 12 months

  27. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months.

    Measured: 12 months

  28. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

    Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

    Measured: 30 days

  29. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

    Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

    Measured: 30 days

  30. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

    Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

    Measured: 30 days

  31. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

    Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

    Measured: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

  32. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

    Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

    Measured: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

  33. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

    Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

    Measured: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

  34. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting.

    rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 7 and 30 days, and at 6, 12, 24, 36 and 60 months

  35. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline.

    Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting.

    rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 7 and 30 days, and at 6 and 12 months

  36. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting.

    rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 7 and 30 days, and at 6, 12, 24, 36 and 60 months

  37. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Aberdeen Varicose Vein Questionnaire (AVVQ) Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 30 days, and at 6, 12, 24, 36, 48 and 60 months

  38. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline.

    The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 30 days, and 6 and 12 months

  39. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 30 days, and at 6, 12, 24, 36 and 60 months

  40. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.

    EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health).

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 30 days, and 6, 12, 24, 36, 48 and 60 months

  41. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline.

    EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health).

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 30 days, and 6 and 12 months

  42. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.

    EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health).

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 30 days, and 6, 12, 24, 36, 48 and 60 months

  43. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

    The total score ranges from 0 to 100, with higher scores indicating better general health perception.

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 30 days, and 6 and 12 months

  44. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

    The total score ranges from 0 to 100, with higher scores indicating better general health perception.

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 30 days, and 6 and 12 months

  45. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

    The total score ranges from 0 to 100, with higher scores indicating better general health perception.

    The outcome measure data reports changes compared to baseline at the different time frames.

    Measured: 30 days, and 6 and 12 months

  46. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad).

    The outcome measure data reports the responses at the different time points compared to baseline.

    Measured: 30 days, and 6, 12, 24, 36, 48, and 60 months

  47. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline.

    The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad).

    The outcome measure data reports the responses at the different time points compared to baseline.

    Measured: 30 days, and 6, 12 months

  48. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad).

    The outcome measure data reports the responses at the different time points compared to baseline.

    Measured: 30 days, and 6, 12, 24, 36, 48, and 60 months

  49. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

    Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

    Measured: Post-index procedure, on the day of the procedure immediately following treatment

  50. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

    Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

    Measured: Post-index procedure, on the day of the procedure immediately following treatment

  51. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

    Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

    Measured: Post-index procedure, on the day of the procedure immediately following treatment

  52. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe).

    Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

    Measured: 30 days

  53. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs).

    Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

    Measured: 30 days

  54. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated.

    Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

    Measured: Post-index procedure, on the day of the procedure immediately following treatment

  55. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit.

    Measured: 60 months

  56. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.

    Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months

    Measured: 60 months

  57. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.

    Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months.

    Measured: 60 months

  58. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 60 Months.

    Measured: 60 months

  59. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 60 Months.

    Measured: 60 months

  60. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months.

    As measured by the time between the index procedure and the first reintervention procedure.

    Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months.

    Measured: 60 months

  61. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months.

    As measured by the time between the index procedure and the first reintervention procedure.

    Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months.

    Measured: 60 months

  62. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Time to Ulcer Recurrence on the Target Limb Following Ulcer Healing Through 60 Months.

    Time to ulcer recurrence reported by using the cumulative incidence probability estimate of the event happening at 60 months, expressed as a percentage. Ulcer recurrence could only occur after the initial ulcer had completely healed.

    Measured: 60 months

  63. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Free Time, Calculated as Days Between Initial Ulcer Healing and First Ulcer Recurrence, as Applicable, Through 60 Months.

    As measured by the time between initial ulcer healing and the first ulcer recurrence.

    Measured: 60 months

  64. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Healing Rate, as Measured by the Percentage of the Ulcer Area Healed, Through 24 Months.

    Ulcer healing rate, as measured by the percentage of the ulcer area healed, according to an independent core laboratory through 24 months or until ulcer healing has been confirmed. This was assessed by overall number of wound care utilizations, and also by different wound care treatments subtypes.

    Measured: 24 months

  65. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Healthcare Utilization and Routine Wound Care Treatments Between Study Visits Through 60 Months.

    Determined by the number of ulcer wound care treatments utilized between study visits through 60 months.

    Measured: 60 months

  66. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Additional Events Evaluated Through 60 Months.

    Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).

    Measured: 60 Months

  67. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Additional Events Evaluated Through 60 Months.

    Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).

    Measured: 60 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2019
  2. Study start5 Feb 2020
  3. Primary completion12 Jun 2024
  4. Study completion10 Nov 2025

Why it stopped: Follow-up of the VenaSeal vs. Endothermal Ablation and Venous Leg Ulcer studies was concluded early due to increased evidence of safety and effectiveness of VenaSeal in published literature and to reduce burden to investigators and sites.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03820947
Sponsor's protocol ID
MDT18034
Status last verified
Jul 2026
First submitted
8 Jan 2019
Last updated
25 Aug 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Gohel M, Gibson K, Falvo N, Park SW, Kim JY, Hirsch T, O'Banion LA, Salkowski N, Ali A, Davies AH; VenaSeal Spectrum Investigators. Randomised Clinical Trials Comparing Cyanoacrylate Closure with Surgical Stripping and Endovenous Thermal Ablation for Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2026 May 26:S1078-5884(26)00465-X. doi: 10.1016/j.ejvs.2026.05.005. Online ahead of print.

    PubMed 42203167

Questions about this trial

What is this clinical trial studying?

A study testing VenaSeal™ System, Endothermal Ablation (ETA) and Surgical Stripping in people with Venous Reflux, run by Medtronic Endovascular at 32 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, South Korea, United Kingdom, France, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. (time frame: 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03820947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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