Clinical trial NCT03820947: VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Venous Reflux
Keywords: Venous reflux
Venous leg ulcer
Varicose Veins
Chronic Venous Insufficiency
VenaSeal
Endothermal Ablation
Surgical Stripping
Radiofrequency Ablation
Laser Ablation
Great Saphenous Vein
Small Saphenous Vein
Anterior Accessory Saphenous Vein
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2019-01-29
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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)

Primary outcomes:
measure: Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
timeFrame: 30 days
measure: Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
timeFrame: 30 days
measure: Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
timeFrame: Index procedure
measure: Time to ulcer healing (For VLU study)
timeFrame: Index procedure through 12 months
Secondary outcomes:
measure: Anatomic closure of the primary target superficial truncal vein
timeFrame: 6 months
measure: Time to return to work
timeFrame: Through study completion, an average of 30 days
measure: Anatomic closure of primary target vein
timeFrame: 30 days, and 12, 24, 36, 48 and 60 months (30 days and 12 months only for VenaSeal vs. Surgical Stripping Study)
measure: Anatomic closure of target vein
timeFrame: 30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Technical success of each target vein
timeFrame: Index procedure
measure: Reintervention of any target vein
timeFrame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Time to reintervention of any target vein
timeFrame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Adverse events (AEs) occurring in the target limb
timeFrame: Index procedure through 12 months
measure: Additional adverse events
timeFrame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Healthcare utilization measured by the number of each type of adjunctive treatment.
timeFrame: Index procedure through 12 months
measure: Healthcare utilization measured by number of healthcare resources and other health related resources utilized for target limb venous reflux disease
timeFrame: Index procedure through 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Healthcare utilization measured by number of healthcare resources utilized for adverse events
timeFrame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
measure: For VLU study only: Healthcare utilization measured by number of ulcer related healthcare resources utilized
timeFrame: Index procedure through 60 months
measure: Time to return to normal activities
timeFrame: Through study completion, an average of 30 days
measure: Intra-procedural and post-procedural pain
timeFrame: Index procedure, and 7 days and 30 days
measure: Change in venous disease symptoms compared to baseline measured by the revised Venous Clinical Severity Score (rVCSS)
timeFrame: 7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Change in venous disease symptoms compared to baseline as measured by subject self-reporting symptoms
timeFrame: 7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline
timeFrame: 30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) compared to baseline
timeFrame: 30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Change in the 36-Item Short Form Health Survey (SF-36) compared to baseline
timeFrame: 30 days, and 6 and 12 months
measure: Change in the Venous Dependent Quality of Life (VenousDQoL) compared to baseline
timeFrame: 30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Provider experience evaluating overall satisfaction with the procedure
timeFrame: Index procedure
measure: For VLU Study: Ulcer recurrence on the target limb
timeFrame: Following ulcer healing through 60 months
measure: For VLU study: Ulcer healing rate
timeFrame: Index procedure through 24 months or until ulcer healing has been confirmed
measure: For VLU Study: Ulcer-free time
timeFrame: Through 60 months
measure: For VLU Study: Venous treatment satisfaction questionnaire-early (VenousTSQe)
timeFrame: 30 days
measure: For VLU Study: Venous treatment satisfaction questionnaire- status (VenousTSQs)
timeFrame: 30 days
measure: For VLU Study: Percentage of target vein treated
timeFrame: Index procedure
Other outcomes:
Locations:
city: Prescott Valley
country: United States
facility: Yavapai Regional Medical Center
state: Arizona
city: Tucson
country: United States
facility: PIMA Heart and Vascular
state: Arizona
city: Fresno
country: United States
facility: Valley Vascular Surgical Associates
state: California
city: Darien
country: United States
facility: Vascular Care Connecticut
state: Connecticut
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Wellesley
country: United States
facility: Vascular Care Group
state: Massachusetts
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
city: Houston
country: United States
facility: Orion Medical
state: Texas
city: Bellevue
country: United States
facility: Lake Washington Vascular
state: Washington
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
city: Wollongong
country: Australia
facility: Wollongong Hospital
city: Toronto
country: Canada
facility: East Toronto Vascular Clinic
state: Ontario
city: Dijon
country: France
facility: CHU Dijon Bourgogne
state: DIjon Cedex
city: Lyon
country: France
facility: Clinique du Parc
city: Toulouse
country: France
facility: Clinique Pasteur
city: Halle
country: Germany
facility: Praxis fur Innere Medizin und Gefäβkrankheiten
city: Milano
country: Italy
facility: Ospedale Fatebenefratelli e Oftalmico
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova Ospendale Sant' Antonio
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Arnhem
country: Netherlands
facility: Rijnstate - Locatie Arnhem
city: Granada
country: Spain
facility: Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)
city: Madrid
country: Spain
facility: Sanitas Hospital Universitario La Zarzuela
city: Bedford
country: United Kingdom
facility: Bedfordshire Hospitals NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
city: Harrow
country: United Kingdom
facility: West London Vascular and Interventional Centre
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital
Study officials:
affiliation: Lake Washington Vascular, US
name: Kathleen Gibson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Addenbrooke's Hospital, UK
name: Manjit Gohel, MD
role: PRINCIPAL_INVESTIGATOR
References: