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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 : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Description
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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:

  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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 806 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 : September 30, 2023
Estimated Study Completion Date : March 30, 2027
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. Time to ulcer healing (For VLU study) [ Time Frame: Index procedure through 24 months ]
    Time to ulcer healing, calculated through healing confirmation and verified by an independent core laboratory.


Secondary Outcome Measures :
  1. 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.

  2. Time to return to work [ Time Frame: Index procedure through 30 days ]
  3. Anatomic closure of primary target vein [ Time Frame: 30 days, and 12, 24, 36, 48 and 60 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.

  4. Anatomic closure of target vein [ Time Frame: 30 days, and 6, 12, 24, 36, 48 and 60 months ]
    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.

  5. 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.

  6. Reintervention of any target vein [ Time Frame: Index procedure through 60 months ]
    Assessed via number of the target veins requiring retreatment.

  7. Time to reintervention of any target vein [ Time Frame: Index procedure through 60 months ]
  8. 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.

  9. Additional adverse events [ Time Frame: Index procedure through 60 months ]
    Additional adverse events that will be evaluated through 60 months are symptomatic pulmonary embolism (PE) and serious adverse events (SAEs).

  10. Number and type of adjunctive treatment conducted [ Time Frame: Index procedure through 12 months ]
  11. Number of healthcare resources utilized for target limb venous reflux disease [ Time Frame: Index procedure through 60 months ]
  12. Number of healthcare resources utilized for adverse events [ Time Frame: Index procedure through 60 months ]
  13. For VLU study only: Number of ulcer related healthcare resources utilized [ Time Frame: Index procedure through 60 months ]
  14. Time to return to normal activities [ Time Frame: Index procedure through 30 days ]
  15. 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.

  16. 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 ]
    rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

  17. 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 ]
  18. Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline [ Time Frame: 30 days, and 6, 12, 24, 36, 48, and 60 months ]
    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.

  19. 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 ]
    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.

  20. 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.

  21. 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 ]
    Measured by 0-5 and 0-7 point (there are two scales in this questionnaire) Likert scale with higher score indicating worst outcome.

  22. 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).

  23. For VLU Study: Ulcer recurrence on the target limb [ Time Frame: Following ulcer healing through 60 months ]
  24. For VLU study: Ulcer healing rate [ Time Frame: Index procedure through 24 months or until ulcer healing has been confirmed ]
  25. For VLU Study: Ulcer-free time [ Time Frame: Through 60 months ]
  26. 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).

  27. 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).

  28. 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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  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)
Contacts and Locations
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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: Sara Ortiz +1 7075432216 sara.o.ortiz@medtronic.com
Contact: Shital Patel +1 7075413256 shital.r.patel@medtronic.com

Locations
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United States, Alabama
Alabama Clinical Therapeutics Recruiting
Birmingham, Alabama, United States, 35235
Contact: Robert Foster, MD    205-833-2228    robert.foster@actstudy.net   
Contact: Jill Andringa    +1 (205) 833-2228    jill.andringa@actstudy.net   
United States, Arizona
Yavapai Regional Medical Center Recruiting
Prescott Valley, Arizona, United States, 86314-2255
Contact: Anil Kumar, MD    928-759-5890    AKumar@yrmc.org   
Contact: Lynn Bessette    +1 928-759-5890    lbessett@yrmc.org   
United States, California
Central Valley Vein and Wound Care Recruiting
Fresno, California, United States, 93291
Contact: Leo Fong, MD    559-578-4062    leo@clinscalemanagement.com   
Contact: Jessica Stolfi    +1 (559)-578-4062    leo@clinscalemanagement.com   
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Robert Attaran, MD    203-785-2063    robert.attaran@yale.edu   
Contact: Juan Carmona    +1 203-785-2063    juan.carmona@yale.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Julianne Stoughton, MD    617-726-4957    jstoughton@mgh.harvard.edu   
Contact: Kathyrn Nuzzolo, MD    +1 617-726-4957    knuzzolo@mgh.harvard.edu   
United States, Texas
Orion Medical Recruiting
Pasadena, Texas, United States, 77505-3165
Contact: Karan Bhalla, MD    713-943-2800    karan.bhalla@orionmedical.net   
Contact: Cherie Morrow    +1 713-943-2800    cherie.morrow@orionmedical.net   
United States, Washington
Lake Washington Vascular Recruiting
Bellevue, Washington, United States, 98004-4623
Contact: Kathleen Gibson, MD    425-453-1772    drgibson@lkwv.com   
Contact: Kim Glorieux    +1 425-453-1772    kimg@lkwv.com   
France
CHU Dijon Bourgogne Recruiting
Dijon, DIjon Cedex, France, 21079
Contact: Dr. Romaric Loffroy    +33-3-80-29-55-86    romaric.loffroy@chu-dijon.fr   
Contact: Mohamed Hedi-Akari    +33-3-80-29-55-86    mohamed-hedi.akari@chu-dijon.fr   
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Dr. Seung-Kee Min    +82 10-7567-8821    skminmd@snuh.org   
Contact: Kwang Woo Choi    +82 10-7567-8821    choikw0528@gmail.com   
Seoul Saint Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Dr. Jang Yong Kim    +82-2-2258-6090    vascularkim@catholic.ac.kr   
Contact: Min Ju Choi    +82-2-2258-2877    lemonia1221@naver.com   
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 143-729
Contact: Sang Woo Park, MD    +82 1095454135    20040017@kuh.ac.kr   
Contact: Eun Young Kim    +82 1095454135    uylovegod@naver.com   
Spain
Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud) Recruiting
Granada, Spain, 18016
Contact: Dr. Luis M Salmerón    +34-958-895-427    lmsalmeron95@gmail.com   
Contact: Eli García Peñalver    +34-958-895-427    eligarpe28@hotmail.com   
Sanitas Hospital Universitario La Zarzuela Recruiting
Madrid, Spain, 28023
Contact: Dr. Juan Fontcuberta    +34 629 88 92 53    jmfontcuberta@sanitas.es   
Contact: Isabel Manzano    +34 629 88 92 53    icarretero@sanitas.es   
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: January 26, 2021
Last Verified: January 2021
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