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VenaSeal Sapheon Closure System Pivotal Study (VeClose) (VeClose)

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ClinicalTrials.gov Identifier: NCT01807585
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : June 26, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Sapheon, Inc.
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.

Condition or disease Intervention/treatment Phase
Great Saphenous Vein (GSV) With Venous Reflux Disease Device: VenaSeal SCS Device: ClosureFast Radiofrequency Ablation (RFA) Device: Roll-in (VenaSeal SCS) Not Applicable

Detailed Description:

The purpose of the VeClose study was to demonstrate safety and effectiveness of the VenaSeal SCS as being both 1) non-inferior to RFA therapy in achieving anatomical closure of lower extremity superficial truncal veins in patients with venous reflux through endovascular transcatheter embolization with coaptation of the GSV at 3 months, and 2) superior in the reduction of intraprocedural and post procedural pain and symptoms as compared to treatment with RFA.

The study was designed to demonstrate safety of the VenaSeal SCS by follow-up visits that evaluated, via duplex ultrasound and physical exam, the presence of deep vein thrombosis and/or pulmonary embolus.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins
Actual Study Start Date : March 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 10, 2017

Arm Intervention/treatment
Experimental: VenaSeal SCS
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA.
Device: VenaSeal SCS
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Other Names:
  • VenaSeal Sapheon Closure System
  • VSCS

Active Comparator: RFA (ClosureFast)
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Heat is applied to the target vein using radiofrequency energy to ablate the target vein. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or RFA.
Device: ClosureFast Radiofrequency Ablation (RFA)
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
Other Name: ClosureFast

Experimental: Roll-in (VenaSeal SCS)
Prior to initiation of the randomized cohort at each site, a non-randomized cohort of 2 subjects per clinical site (roll-in phase) were enrolled and treated with VenalSeal SCS with endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc.
Device: Roll-in (VenaSeal SCS)
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Other Names:
  • VenaSeal Sapheon Closure System
  • VSCS
  • Roll-in




Primary Outcome Measures :
  1. Number of Participants With Complete Closure of the Target Vein at 3 Months [ Time Frame: 3 months ]
    The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.


Secondary Outcome Measures :
  1. Intraoperative Pain [ Time Frame: During the operative procedure, which was an average of 24 minutes for VenaSeal SCS, 19 minutes for RFA, and 31 minutes for Roll-in group. ]
    After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.

  2. Ecchymosis at Day 3 [ Time Frame: First follow up visit at day 3 ]

    At the Day 3 visit, the investigator visually rated the subject's ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis Assessment with a 0-5 rating scale, with 0 being the best possible outcome and 5 being the worst possible outcome.

    The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site.

    The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria:

    0 rating = no ecchymosis,

    1. rating = less than 25% ecchymosis,
    2. rating = 25-50% ecchymosis,
    3. rating = 50-75% ecchymosis,
    4. rating = 75-100% ecchymosis,
    5. rating = extension of ecchymosis above or below the treated area.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 21 years and ≤ 70 years of age at the time of screening
  2. Reflux in the great saphenous vein (GSV) greater than 0.5 sec reflux
  3. One or more of the following symptoms related to the target vein: aching, throbbing, heaviness, fatigue, pruritis, night cramps, restlessness, generalized pain or discomfort, swelling
  4. GSV diameter while standing of 3-12 mm throughout the target vein as measured by Duplex ultrasound
  5. Clinical, etiology, assessment and pathophysiology (CEAP) classification of C2 (if symptomatic) - C4b
  6. Ability to walk unassisted
  7. Ability to attend follow-up visits
  8. Ability to understand the requirements of the study and to provide informed consent

Exclusion Criteria:

  1. Life expectancy < 1 year
  2. Active treatment for malignancy other than non-melanoma skin cancer
  3. Symptomatic peripheral arterial disease with ankle-brachial index (ABI) <0.89
  4. Daily use of narcotic or non-steroidal anti-inflammatory pain medications to control pain associated with GSV reflux
  5. Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)
  6. Previous or suspected deep vein thrombosis (DVT) or pulmonary embolus (PE)
  7. Previous superficial thrombophlebitis in GSV
  8. Previous treatment of venous disease in target limb, other than spider vein treatment
  9. Known hypercoagulable disorder
  10. Conditions which prevent vein treatment with either RFA or VenaSeal SCS
  11. Immobilization or inability to ambulate
  12. Pregnant prior to enrollment
  13. Tortuous GSV, which, in the opinion of the investigator, will limit catheter placement or require more than one primary access site
  14. Aneurysm of the target vein with local diameter >12 mm
  15. Significant, incompetent, ipsilateral small saphenous, intersaphenous or anterior accessory great saphenous vein(s)
  16. Known sensitivity to cyanoacrylate (CA) adhesives
  17. Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment
  18. Patients who require bilateral treatment during the next 3 months
  19. Patients who require 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): NCT01807585


Locations
United States, Arizona
Morrison Vein Institute
Scottsdale, Arizona, United States, 85255
United States, California
GBK Cosmetic Laser Dermatology
San Diego, California, United States, 92121
United States, Colorado
Radiology Imaging Associates (RIA)
Greenwood Village, Colorado, United States, 80111
United States, Illinois
Vein Clinics of America
Oakbrook Terrace, Illinois, United States, 60181
Prairie Education & Research Cooperative
Springfield, Illinois, United States, 62701
United States, Maryland
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, New York
Vein Institute of Buffalo
North Tonawanda, New York, United States, 14120
United States, Oregon
Inovia Vein Specialty Center
Bend, Oregon, United States, 97701
United States, Virginia
Sentara Vascular Specialist
Virginia Beach, Virginia, United States, 23452
United States, Washington
Lake Washington Vascular
Bellevue, Washington, United States, 98004-4623
Sponsors and Collaborators
Medtronic Endovascular
Sapheon, Inc.
Investigators
Principal Investigator: Nick Morrison, MD Morrison Vein Institute