VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

NCT03820947 | Terminated Results FDA Device

• 1 other identifier: MDT18034
• Study Type: interventional
• Target: 506
• Locations: 10 countries
• Sites: 32

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

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

Outcome Measures

Primary Outcomes (7)

• 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.

  30 days

• 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.

  30 days

• 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.

  30 days

• 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.

  30 days

• 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.

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

• 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.

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

• 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.

  12 months

Secondary Outcomes (53)

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

  6 months

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

  6 months

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

  6 months

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

  30 days

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

  30 days

Study Arms (5)

Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): VenaSeal™ System

EXPERIMENTAL

CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA

Device: VenaSeal™ System

Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): ETA

ACTIVE COMPARATOR

CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA

Device: Endothermal Ablation (ETA)

Randomized study VenaSeal™ System versus Surgical Stripping: VenaSeal™ System

EXPERIMENTAL

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

Device: VenaSeal™ System

Randomized study VenaSeal™ System versus Surgical Stripping: Surgical Stripping

ACTIVE COMPARATOR

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

Procedure: Surgical Stripping

Single arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System

EXPERIMENTAL

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

Device: VenaSeal™ System

Interventions

VenaSeal™ System DEVICE

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

Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): VenaSeal™ System; Randomized study VenaSeal™ System versus Surgical Stripping: VenaSeal™ System; Single arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System

Endothermal Ablation (ETA) DEVICE

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.

Also known as: Endovenous laser ablation (EVLA), Radiofrequency ablation (RFA)

Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): ETA

Surgical Stripping PROCEDURE

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

Randomized study VenaSeal™ System versus Surgical Stripping: Surgical Stripping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (32)

Yavapai Regional Medical Center

Prescott Valley, Arizona, 86314-2255, United States

Location

PIMA Heart and Vascular

Tucson, Arizona, 85718, United States

Location

Valley Vascular Surgical Associates

Fresno, California, 93701, United States

Location

Vascular Care Connecticut

Darien, Connecticut, 06820, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Georgetown University Medical Center

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

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Vascular Care Group

Wellesley, Massachusetts, 02482, United States

Location

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10024, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Orion Medical

Houston, Texas, 77034, United States

Location

Lake Washington Vascular

Bellevue, Washington, 98004-4623, United States

Location

Sunshine Coast University Hospital

Birtinya, 4575, Australia

Location

Wollongong Hospital

Wollongong, Australia

Location

East Toronto Vascular Clinic

Toronto, Ontario, M4L 3Y3, Canada

Location

CHU Dijon Bourgogne

Dijon, DIjon Cedex, 21079, France

Location

Clinique du Parc

Lyon, 69006, France

Location

Clinique Pasteur

Toulouse, France

Location

Praxis fur Innere Medizin und Gefäβkrankheiten

Halle, 06108, Germany

Location

Ospedale Fatebenefratelli e Oftalmico

Milan, 20121, Italy

Location

Azienda Ospedaliera di Padova Ospendale Sant' Antonio

Padua, 35127, Italy

Location

Rijnstate - Locatie Arnhem

Arnhem, 6815, Netherlands

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Seoul Saint Mary's Hospital

Seoul, 137-701, South Korea

Location

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)

Granada, 18016, Spain

Location

Sanitas Hospital Universitario La Zarzuela

Madrid, 28023, Spain

Location

Bedfordshire Hospitals NHS Foundation Trust

Bedford, MK42 9DJ, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

West London Vascular and Interventional Centre

Harrow, HA1 3UJ, United Kingdom

Location

Imperial College Healthcare NHS Trust - Charing Cross Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer; Varicose Veins

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Wendy Moeyersons, Clinical Research Specialist
• Organization: Medtronic

wendy.moeyersons@medtronic.com

+32486313172

Study Officials

• Kathleen Gibson, MD

  Lake Washington Vascular, US

  PRINCIPAL INVESTIGATOR

• Manjit Gohel, MD

  Addenbrooke's Hospital, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 29, 2019
• Study Start: February 5, 2020
• Primary Completion: June 12, 2024
• Study Completion: November 10, 2025
• Last Updated: December 30, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); GB (4); IT (2); DE (1); AU (2); KR (4); CA (1); NL (1); ES (2); FR (3)