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

Primary Purpose

Great Saphenous Vein (GSV) With Venous Reflux Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VenaSeal SCS
ClosureFast Radiofrequency Ablation (RFA)
Roll-in (VenaSeal SCS)
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Great Saphenous Vein (GSV) With Venous Reflux Disease focused on measuring GSV

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Morrison Vein Institute
  • GBK Cosmetic Laser Dermatology
  • Radiology Imaging Associates (RIA)
  • Vein Clinics of America
  • Prairie Education & Research Cooperative
  • MD Laser Skin & Vein Institute
  • Vein Institute of Buffalo
  • Inovia Vein Specialty Center
  • Sentara Vascular Specialist
  • Lake Washington Vascular

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

VenaSeal SCS

RFA (ClosureFast)

Roll-in (VenaSeal SCS)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Complete Closure of the Target Vein at 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

Intraoperative Pain
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
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, rating = less than 25% ecchymosis, rating = 25-50% ecchymosis, rating = 50-75% ecchymosis, rating = 75-100% ecchymosis, rating = extension of ecchymosis above or below the treated area.

Full Information

First Posted
March 5, 2013
Last Updated
May 29, 2018
Sponsor
Medtronic Endovascular
Collaborators
Sapheon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01807585
Brief Title
VenaSeal Sapheon Closure System Pivotal Study (VeClose)
Acronym
VeClose
Official Title
VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
Collaborators
Sapheon, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Great Saphenous Vein (GSV) With Venous Reflux Disease
Keywords
GSV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VenaSeal SCS
Arm Type
Experimental
Arm Description
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.
Arm Title
RFA (ClosureFast)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Roll-in (VenaSeal SCS)
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
VenaSeal SCS
Other Intervention Name(s)
VenaSeal Sapheon Closure System, VSCS
Intervention Description
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Intervention Type
Device
Intervention Name(s)
ClosureFast Radiofrequency Ablation (RFA)
Other Intervention Name(s)
ClosureFast
Intervention Description
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
Intervention Type
Device
Intervention Name(s)
Roll-in (VenaSeal SCS)
Other Intervention Name(s)
VenaSeal Sapheon Closure System, VSCS, Roll-in
Intervention Description
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Primary Outcome Measure Information:
Title
Number of Participants With Complete Closure of the Target Vein at 3 Months
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Intraoperative Pain
Description
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.
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.
Title
Ecchymosis at Day 3
Description
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, rating = less than 25% ecchymosis, rating = 25-50% ecchymosis, rating = 50-75% ecchymosis, rating = 75-100% ecchymosis, rating = extension of ecchymosis above or below the treated area.
Time Frame
First follow up visit at day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 21 years and ≤ 70 years of age at the time of screening Reflux in the great saphenous vein (GSV) greater than 0.5 sec reflux 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 GSV diameter while standing of 3-12 mm throughout the target vein as measured by Duplex ultrasound Clinical, etiology, assessment and pathophysiology (CEAP) classification of C2 (if symptomatic) - C4b Ability to walk unassisted Ability to attend follow-up visits Ability to understand the requirements of the study and to provide informed consent Exclusion Criteria: Life expectancy < 1 year Active treatment for malignancy other than non-melanoma skin cancer Symptomatic peripheral arterial disease with ankle-brachial index (ABI) <0.89 Daily use of narcotic or non-steroidal anti-inflammatory pain medications to control pain associated with GSV reflux Current, regular use of systemic anticoagulation (e.g., warfarin, heparin) Previous or suspected deep vein thrombosis (DVT) or pulmonary embolus (PE) Previous superficial thrombophlebitis in GSV Previous treatment of venous disease in target limb, other than spider vein treatment Known hypercoagulable disorder Conditions which prevent vein treatment with either RFA or VenaSeal SCS Immobilization or inability to ambulate Pregnant prior to enrollment Tortuous GSV, which, in the opinion of the investigator, will limit catheter placement or require more than one primary access site Aneurysm of the target vein with local diameter >12 mm Significant, incompetent, ipsilateral small saphenous, intersaphenous or anterior accessory great saphenous vein(s) Known sensitivity to cyanoacrylate (CA) adhesives Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment Patients who require bilateral treatment during the next 3 months Patients who require additional ipsilateral treatments on the same leg within 3 months following treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Morrison, MD
Organizational Affiliation
Morrison Vein Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morrison Vein Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
GBK Cosmetic Laser Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Radiology Imaging Associates (RIA)
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Vein Clinics of America
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Prairie Education & Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
MD Laser Skin & Vein Institute
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Facility Name
Vein Institute of Buffalo
City
North Tonawanda
State/Province
New York
ZIP/Postal Code
14120
Country
United States
Facility Name
Inovia Vein Specialty Center
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Sentara Vascular Specialist
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Lake Washington Vascular
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004-4623
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28411697
Citation
Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.
Results Reference
result
PubMed Identifier
27638993
Citation
Kolluri R, Gibson K, Cher D, Madsen M, Weiss R, Morrison N. Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. Epub 2016 Aug 8.
Results Reference
result
PubMed Identifier
29914814
Citation
Gibson K, Morrison N, Kolluri R, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):606-613. doi: 10.1016/j.jvsv.2018.04.009. Epub 2018 Jun 15.
Results Reference
derived
PubMed Identifier
25650040
Citation
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.
Results Reference
derived

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VenaSeal Sapheon Closure System Pivotal Study (VeClose)

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