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

NCT02585726 | Completed

• 1 other identifier: 2015-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Venous Reflux

Keywords

Varicose Veins; Great Saphenous Vein; Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.

  CC of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.

  1 month

Secondary Outcomes (11)

• CC of the PTVS, as assessed by duplex ultrasound

  1 week and 3 months after treatment

• CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound

  1 month and 3 months after the index procedure

• Quality of life as measured by the venous clinical severity scores (rVCSS)

  1 and 3 months after treatment

• Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ)

  1 and 3 months after treatment

• Quality of life as measured by the EQ-5D

  1 and 3 months after treatment

Study Arms (2)

Historical Control with Propensity Analysis

ACTIVE COMPARATOR

Device: SP-402 VenaSeal™ Closure System

VenaSeal Treatment Arm

EXPERIMENTAL

Device: SP-402 VenaSeal™ Closure System

Interventions

SP-402 VenaSeal™ Closure System DEVICE

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..

Also known as: VenaSeal™

Historical Control with Propensity Analysis; VenaSeal Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lake Washington Vascular: lead
• Syntactx: collaborator

Study Sites (1)

Lake Washington Vascular, PLLC

Bellevue, Washington, 98004, United States

Location

Related Publications (14)

• Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.

  PMID: 21536172 BACKGROUND

• Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.

  PMID: 15723761 BACKGROUND

• van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.

  PMID: 18692348 BACKGROUND

• Geza M, Gloviczki P. Venous Embryology and Anatomy. In: Bergan JJ, editor. The Vein Book: Elsivier Academic Press; 2007.

  BACKGROUND

• van Eekeren RR, Boersma D, de Vries JP, Zeebregts CJ, Reijnen MM. Update of endovenous treatment modalities for insufficient saphenous veins--a review of literature. Semin Vasc Surg. 2014 Jun;27(2):118-36. doi: 10.1053/j.semvascsurg.2015.02.002. Epub 2015 Feb 18.

  PMID: 25868763 BACKGROUND

• Guex JJ. Endovenous chemical (and physical) treatments for varices: what's new? Phlebology. 2014 May;29(1 suppl):45-48. doi: 10.1177/0268355514526331. Epub 2014 May 19.

  PMID: 24843085 BACKGROUND

• Davies HO, Popplewell M, Darvall K, Bate G, Bradbury AW. A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins. Phlebology. 2016 May;31(4):234-40. doi: 10.1177/0268355515595194. Epub 2015 Jul 9.

  PMID: 26163507 BACKGROUND

• El-Sheikha J, Carradice D, Nandhra S, Leung C, Smith GE, Campbell B, Chetter IC. Systematic review of compression following treatment for varicose veins. Br J Surg. 2015 Jun;102(7):719-25. doi: 10.1002/bjs.9788. Epub 2015 Apr 2.

  PMID: 25833417 BACKGROUND

• Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555.

  PMID: 21725957 BACKGROUND

• Bootun R, Lane TR, Davies AH. The advent of non-thermal, non-tumescent techniques for treatment of varicose veins. Phlebology. 2016 Feb;31(1):5-14. doi: 10.1177/0268355515593186. Epub 2015 Jun 30.

  PMID: 26130051 BACKGROUND

• Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.

  PMID: 25650040 BACKGROUND

• Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 2015 Jul;30(6):397-404. doi: 10.1177/0268355514532455. Epub 2014 Apr 30.

  PMID: 24789750 BACKGROUND

• Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Cher D, Davies A. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):2-7. doi: 10.1016/j.jvsv.2014.09.001. Epub 2014 Oct 18.

  PMID: 26993674 BACKGROUND

• Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27.

  PMID: 20875713 BACKGROUND

MeSH Terms

Conditions

Varicose Veins; Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 23, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 16, 2018

Record last verified: 2018-03

Locations

US (1)