VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03820947

Recruitment Status : Recruiting

First Posted : January 29, 2019

Last Update Posted : March 3, 2023

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Sponsor:

Information provided by (Responsible Party):

Medtronic Endovascular

Study Description

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

Condition or disease	Intervention/treatment	Phase
Venous Reflux	Device: VenaSeal™ Closure System Device: Endothermal Ablation (ETA) Procedure: Surgical Stripping	Not Applicable

Detailed Description:

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

Two randomized studies are for CEAP 2-5 subjects:

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

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

1. VLU Study

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Actual Study Start Date :	February 5, 2020
Estimated Primary Completion Date :	April 30, 2024
Estimated Study Completion Date :	April 30, 2028

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study) [ Time Frame: 30 days ]
Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).
Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study) [ Time Frame: 30 days ]
Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).
Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study) [ Time Frame: 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.
Time to ulcer healing (For VLU study) [ Time Frame: Index procedure through 12 months ]
Time to ulcer healing, calculated through healing confirmation and verified by an independent core laboratory.

Secondary Outcome Measures :

Anatomic closure of the primary target superficial truncal vein [ Time Frame: 6 months ]
Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.
Time to return to work [ Time Frame: Through study completion, an average of 30 days ]
Anatomic closure of primary target vein [ Time Frame: 30 days, and 12, 24, 36, 48 and 60 months (30 days and 12 months only for VenaSeal vs. Surgical Stripping Study) ]
Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.
Anatomic closure of target vein [ Time Frame: 30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study) ]
Measured via Duplex Ultrasound showing target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.
Technical success of each target vein [ Time Frame: Index procedure ]
Measured via Duplex Ultrasound showing target vein (including primary target vein) closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.
Reintervention of any target vein [ Time Frame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study) ]
Assessed via number of the target veins requiring retreatment.
Time to reintervention of any target vein [ Time Frame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study) ]
Adverse events (AEs) occurring in the target limb [ Time Frame: Index procedure through 12 months ]
Adverse events occurring in target limb, evaluated from index procedure through 12 months are hypersensitivity to VenaSeal™ adhesive, phlebitis, granuloma, endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), symptomatic deep vein thrombosis (DVT) events.
Additional adverse events [ Time Frame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study) ]
Additional adverse events that will be evaluated through 60 months are symptomatic pulmonary embolism (PE) and serious adverse events (SAEs).
Healthcare utilization measured by the number of each type of adjunctive treatment. [ Time Frame: Index procedure through 12 months ]
Healthcare utilization measured by number of healthcare resources and other health related resources utilized for target limb venous reflux disease [ Time Frame: Index procedure through 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study) ]
Healthcare utilization measured by number of healthcare resources utilized for adverse events [ Time Frame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study) ]
For VLU study only: Healthcare utilization measured by number of ulcer related healthcare resources utilized [ Time Frame: Index procedure through 60 months ]
Time to return to normal activities [ Time Frame: Through study completion, an average of 30 days ]
Intra-procedural and post-procedural pain [ Time Frame: 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.
Change in venous disease symptoms compared to baseline measured by the revised Venous Clinical Severity Score (rVCSS) [ Time Frame: 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) ]
rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.
Change in venous disease symptoms compared to baseline as measured by subject self-reporting symptoms [ Time Frame: 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) ]
Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline [ Time Frame: 30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study) ]
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.
Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) compared to baseline [ Time Frame: 30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study) ]
Items are scored on a 1-5 scale, 5 being a worse outcome. Each of the 5 dimensions are scored separately to obtain a 5-digit code which is converted into a standard value by country. Max & min values vary by country.
Change in the 36-Item Short Form Health Survey (SF-36) compared to baseline [ Time Frame: 30 days, and 6 and 12 months ]
The total score ranges from 0 to 100, with higher scores indicating better general health perception.
Change in the Venous Dependent Quality of Life (VenousDQoL) compared to baseline [ Time Frame: 30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study) ]
Measured by 0-5 and 0-7 point (there are two scales in this questionnaire) Likert scale with higher score indicating worst outcome.
Provider experience evaluating overall satisfaction with the procedure [ Time Frame: Index procedure ]
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
For VLU Study: Ulcer recurrence on the target limb [ Time Frame: Following ulcer healing through 60 months ]
For VLU study: Ulcer healing rate [ Time Frame: Index procedure through 24 months or until ulcer healing has been confirmed ]
For VLU Study: Ulcer-free time [ Time Frame: Through 60 months ]
For VLU Study: Venous treatment satisfaction questionnaire-early (VenousTSQe) [ Time Frame: 30 days ]
Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).
For VLU Study: Venous treatment satisfaction questionnaire- status (VenousTSQs) [ Time Frame: 30 days ]
Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).
For VLU Study: Percentage of target vein treated [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 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
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

Exclusion Criteria:

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 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)
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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820947

Contacts

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Contact: Shital Patel	+1 7075413256	shital.r.patel@medtronic.com
Contact: Analyn Jackson	+1 2146979894	analyn.u.jackson@medtronic.com

Locations

Show 35 study locations

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United States, Alabama
Alabama Clinical Therapeutics	Withdrawn
Birmingham, Alabama, United States, 35235
United States, Arizona
Yavapai Regional Medical Center	Active, not recruiting
Prescott Valley, Arizona, United States, 86314-2255
PIMA Heart and Vascular	Recruiting
Tucson, Arizona, United States, 85718
Contact: Dr. Joshua Balderman
Contact: Manuel Ortiz
United States, California
Valley Vascular Surgical Associates	Recruiting
Fresno, California, United States, 93701
Contact: Leigh Ann O'Banion, MD
Contact: Ashley Gutierrez
Central Valley Vein and Wound Care	Withdrawn
Visalia, California, United States, 93291
United States, Connecticut
Vascular Care Connecticut	Recruiting
Darien, Connecticut, United States, 06820
Contact: Paul Gagne, MD
Contact: Elizabeth Gagne, PhD
Yale School of Medicine	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Robert Attaran, MD
Contact: Juan Carmona
United States, District of Columbia
Georgetown University Medical Center	Recruiting
Washington, District of Columbia, United States, 20007-2113
Contact: Dr. Misaki Kiguchi
Contact: Benjamin Roberts
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Julianne Stoughton, MD
Contact: Kathryn Nuzzolo
Vascular Care Group	Recruiting
Wellesley, Massachusetts, United States, 02482
Contact: Robert Lancaster, MD
Contact: Elizabeth Gagne, PhD
United States, New York
New York-Presbyterian Hospital/Weill Cornell Medical Center	Recruiting
New York, New York, United States, 10024
Contact: Neil Khilnani, MD
Contact: Irina Lipai
United States, Ohio
OhioHealth Riverside Methodist Hospital	Terminated
Columbus, Ohio, United States, 43214
United States, Texas
Orion Medical	Recruiting
Pasadena, Texas, United States, 77505-3165
Contact: Karan Bhalla, MD
Contact: Dulse Flores
United States, Washington
Lake Washington Vascular	Recruiting
Bellevue, Washington, United States, 98004-4623
Contact: Kathleen Gibson, MD
Contact: Kim Glorieux
Australia
Sunshine Coast University Hospital	Active, not recruiting
Birtinya, Australia, 4575
Wollongong Hospital	Active, not recruiting
Wollongong, Australia
Canada, Ontario
East Toronto Vascular Clinic	Recruiting
Toronto, Ontario, Canada, M4L 3Y3
Contact: Ahmed Kayssi, MD
Contact: Leslie Summers deLuca
France
CHU Dijon Bourgogne	Active, not recruiting
Dijon, DIjon Cedex, France, 21079
Clinique du Parc	Recruiting
Lyon, France, 69006
Contact: Dr. Philippe Nicolini
Contact: Nina Pronina
Clinique Pasteur	Recruiting
Toulouse, France
Contact: Dr. Nicolas Neaume
Contact: Cécile Jarlier
Germany
Praxis fur Innere Medizin und Gefäβkrankheiten	Active, not recruiting
Halle, Germany, 06108
Italy
Azienda Ospedaliera di Padova Ospendale Sant' Antonio - I piano Day Hospital	Recruiting
Padova, Italy, 35127
Contact: Dr. Patrizia Pavei
Korea, Republic of
Seoul National University Hospital	Active, not recruiting
Seoul, Korea, Republic of, 110-744
Seoul Saint Mary's Hospital	Active, not recruiting
Seoul, Korea, Republic of, 137-701
Konkuk University Medical Center	Active, not recruiting
Seoul, Korea, Republic of, 143-729
Gangnam Severance Hospital	Active, not recruiting
Seoul, Korea, Republic of
Netherlands
Rijnstate - Locatie Arnhem	Recruiting
Arnhem, Netherlands, 6815
Contact: Dr. Michel Reijnen
Contact: Daphne van der Veen
Spain
Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)	Active, not recruiting
Granada, Spain, 18016
Hospital Central de la Cruz Roja	Recruiting
Madrid, Spain, 28003
Contact: Lourdes Reina Gutiérrez, MD
Contact: Sergio Gómez del Rio
Sanitas Hospital Universitario La Zarzuela	Recruiting
Madrid, Spain, 28023
Contact: Dr. Juan Fontcuberta
Contact: Isabel Manzano
Switzerland
Hôpital de Morges - Ensemble Hospitalier de la Côte	Completed
Morges, Switzerland
United Kingdom
Bedfordshire Hospitals NHS Foundation Trust	Recruiting
Bedford, United Kingdom, MK42 9DJ
Contact: Dr. Mojahid Najem
Contact: Rachel Lorusso
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital	Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Dr. Manj Gohel
Contact: Aileen Nacorda
West London Vascular and Interventional Centre	Recruiting
Harrow, United Kingdom, HA1 3UJ
Contact: Dr. Tahir Hussain
Contact: Sean Connarty
Imperial College Healthcare NHS Trust - Charing Cross Hospital	Recruiting
London, United Kingdom, W12 0HS
Contact: Dr. Alun Davies
Contact: Caitlin Carr

Sponsors and Collaborators

Medtronic Endovascular

Investigators

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Principal Investigator:	Kathleen Gibson	Lake Washington Vascular, US
Principal Investigator:	Manjit Gohel	Addenbrooke's Hospital, UK

More Information

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Responsible Party:	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT03820947
Other Study ID Numbers:	MDT18034
First Posted:	January 29, 2019 Key Record Dates
Last Update Posted:	March 3, 2023
Last Verified:	March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by Medtronic Endovascular:


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

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