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Lake Washington Vascular VenaSeal™ Post-Market Evaluation (WAVES) (WAVES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02585726
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
Lake Washington Vascular

Brief Summary:
The VenaSeal Closure system offers an outpatient treatment option for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).

Condition or disease Intervention/treatment Phase
Venous Reflux Device: SP-402 VenaSeal™ Closure System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lake Washington Vascular VenaSeal™ Post-Market Evaluation: WAVES
Study Start Date : October 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Active Comparator: Historical Control with Propensity Analysis Device: SP-402 VenaSeal™ Closure System
A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..
Other Name: VenaSeal™

Experimental: VenaSeal Treatment Arm Device: SP-402 VenaSeal™ Closure System
A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..
Other Name: VenaSeal™




Primary Outcome Measures :
  1. Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure. [ Time Frame: 1 month ]
    CC of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.


Secondary Outcome Measures :
  1. CC of the PTVS, as assessed by duplex ultrasound [ Time Frame: 1 week and 3 months after treatment ]
  2. CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound [ Time Frame: 1 month and 3 months after the index procedure ]
  3. Quality of life as measured by the venous clinical severity scores (rVCSS) [ Time Frame: 1 and 3 months after treatment ]
  4. Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ) [ Time Frame: 1 and 3 months after treatment ]
  5. Quality of life as measured by the EQ-5D [ Time Frame: 1 and 3 months after treatment ]
  6. Return to normal activities and return to work; day of procedure is day 0 [ Time Frame: 1 week, 1 month ]
  7. Need for adjunctive treatment [ Time Frame: 3 months ]
    Measured in case report form (yes or no, and if yes, the Investigator will specify what the adjunctive measure is).

  8. Safety and adverse event for below the knee greater saphenous vein treatment [ Time Frame: 1 week, 1 month, 3 months ]
  9. Safety and adverse events for large diameter TVS defined as veins larger than 8 mm in diameter [ Time Frame: 1 week, 1 month, 3 months ]
  10. Patient satisfaction [ Time Frame: 1 week, 1 month, 3 months ]
    At selected visits, the subject will complete a brief questionnaire rating satisfaction with treatment provided and whether the subject would undergo the treatment again.

  11. CC of TVS, expressed on a per-segment basis [ Time Frame: 1 month and 3 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Reflux in at least one target vein;
  • One or more of the following symptoms related to a TV: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling;
  • CEAP classification of C2 (if symptomatic) through C5;

Key Exclusion Criteria:

  • Current, regular use of systemic anticoagulation;
  • Previous or suspected deep vein thrombosis or pulmonary embolus, or active acute superficial thrombophlebitis, or thrombophlebitis migrans;
  • Previous treatment such as laser or radiofrequency ablation of venous disease in targeted vein segment;
  • Known hypercoagulable disorder;
  • Pregnant or breast feeding at enrollment;
  • Known sensitivity to cyanoacrylate adhesives;
  • Venous treatment in the contralateral limb within the last 30 days, or who require contralateral treatment within three months;
  • Planned to undergo additional ipsilateral treatments on the same leg within 3 months following treatment.

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): NCT02585726


Locations
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United States, Washington
Lake Washington Vascular, PLLC
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Lake Washington Vascular
Syntactx
Publications:
Geza M, Gloviczki P. Venous Embryology and Anatomy. In: Bergan JJ, editor. The Vein Book: Elsivier Academic Press; 2007.

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Responsible Party: Lake Washington Vascular
ClinicalTrials.gov Identifier: NCT02585726    
Other Study ID Numbers: 2015-01
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Keywords provided by Lake Washington Vascular:
Varicose Veins
Great Saphenous Vein
Venous Insufficiency