Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patient is ≥18 years of age 2. 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 DUS 3. 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 4. Treatable refluxing segment of target vein(s) 10 cm in length or longer 5. 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 6. Patient is willing and capable of complying with specified follow-up evaluations at the specified times 7. Patient has an ability to understand the requirements of the study and to provide informed consent

Exclusion Criteria

  1. 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 2. Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care 3. Patient has abnormal pulse exam or ABI <0.8 4. Patient has acute superficial thrombophlebitis 5. 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 6. 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) 7. 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) 8. Patient is non-ambulatory 9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure 10. 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 11. 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 12. Patient has documented or suspected (by a clinician) COVID-19 infection currently or within the past 6 months. 13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory 14. 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VenaSeal™ Closure System
CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping
  • Device: VenaSeal™ Closure System
    The VenaSeal™ closure system is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Active Comparator
Endothermal Ablation (ETA)
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA
  • Device: Endothermal Ablation (ETA)
    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.
    Other names:
    • Endovenous laser ablation(EVLA)
    • Radiofrequency ablation (RFA)
Active Comparator
Surgical Stripping
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)
  • Procedure: Surgical Stripping
    Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
Other
VenaSeal™ Closure System VLU Study
CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System
  • Device: VenaSeal™ Closure System
    The VenaSeal™ closure system is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Julianne Stoughton, MD
617-726-4957
jstoughton@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Medtronic Endovascular

Study Contact

Sara Ortiz
+1 7075432216
sara.o.ortiz@medtronic.com

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.