VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

Medtronic

Status: Active, not recruiting

Conditions: Venous Reflux

Treatments: Device: Endothermal Ablation (ETA); Device: VenaSeal™ Closure System; Procedure: Surgical Stripping

Study type: Interventional

Funder types: Industry

Identifiers

NCT03820947

MDT18034

Details and patient eligibility

About

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

Full 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

Enrollment: 506 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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506 participants in 4 patient groups

VenaSeal™ Closure System

Experimental group

Description:

CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping

Treatment:

Device: VenaSeal™ Closure System

Endothermal Ablation (ETA)

Active Comparator group

Description:

CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA

Treatment:

Device: Endothermal Ablation (ETA)

Surgical Stripping

Active Comparator group

Description:

CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)

Treatment:

Procedure: Surgical Stripping

VenaSeal™ Closure System VLU Study

Other group

Description:

CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System

Treatment:

Device: VenaSeal™ Closure System