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

May 29, 2018 updated by: Medtronic Endovascular

VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
First follow up visit at day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Endovascular

Collaborators

Sapheon, Inc.

Investigators

  • Principal Investigator: Nick Morrison, MD, Morrison Vein Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 10, 2017

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-11101-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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