Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Tracking Information
First Submitted Date  ICMJE March 5, 2013
First Posted Date  ICMJE March 8, 2013
Results First Submitted Date  ICMJE February 5, 2018
Results First Posted Date  ICMJE June 26, 2018
Last Update Posted Date June 26, 2018
Actual Study Start Date  ICMJE March 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
Complete closure of the target vein [ Time Frame: 3 months ]
The primary endpoint of the study is complete closure of the target vein where complete closure is defined as Doppler US showing vein closure along entire treated vein segment with no discrete segments of patency exceeding 5 cm as read by a qualified site technologist or investigator with reading from a Vascular Core Lab.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
  • Intraoperative Pain [ Time Frame: After the procedure is complete ]
    The subject will be asked to rate pain experienced during various aspects of the treatment procedure on a 0-10 numeric rating scale
  • Complete closure of target vein [ Time Frame: 12 months ]
    The primary endpoint of the study is complete closure of the target vein where complete closure is defined as Doppler US showing vein closure along entire treated vein segment with no discrete segments of patency exceeding 5 cm as read by a qualified site technologist or investigator.
  • Post operative pain [ Time Frame: 3 days post procedure ]
    The subject will be asked to rate pain experienced during first three (3) days post treatment procedure on a 0-10 numeric rating scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 6, 2013)
Ecchymosis at Day 3 [ Time Frame: First FU visit day 3 ]
The investigator will score the subject's ipsilateral leg for the occurrence of ecchymosis along the area treated
 
Descriptive Information
Brief Title  ICMJE VenaSeal Sapheon Closure System Pivotal Study (VeClose)
Official Title  ICMJE VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Great Saphenous Vein (GSV) With Venous Reflux Disease
Intervention  ICMJE
  • 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
  • Device: ClosureFast Radiofrequency Ablation (RFA)
    Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
    Other Name: ClosureFast
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: VenaSeal SCS
  • 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.
    Intervention: Device: ClosureFast Radiofrequency Ablation (RFA)
  • 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.
    Intervention: Device: Roll-in (VenaSeal SCS)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2018)
242
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2013)
244
Actual Study Completion Date  ICMJE April 10, 2017
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01807585
Other Study ID Numbers  ICMJE CP-11101-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Endovascular
Study Sponsor  ICMJE Medtronic Endovascular
Collaborators  ICMJE Sapheon, Inc.
Investigators  ICMJE
Principal Investigator: Nick Morrison, MD Morrison Vein Institute
PRS Account Medtronic Endovascular
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP