NCT01807585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 26, 2018

Completed
Last Updated

June 26, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

March 5, 2013

Results QC Date

February 5, 2018

Last Update Submit

May 29, 2018

Conditions

Great Saphenous Vein (GSV) With Venous Reflux Disease

Keywords

GSV

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (2)

  • Intraoperative 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

    First follow up visit at day 3

Study Arms (3)

VenaSeal SCS

EXPERIMENTAL

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

RFA (ClosureFast)

ACTIVE COMPARATOR

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)

Roll-in (VenaSeal SCS)

EXPERIMENTAL

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)

Interventions

VenaSeal SCSDEVICE

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Also known as: VenaSeal Sapheon Closure System, VSCS
VenaSeal SCS
ClosureFast Radiofrequency Ablation (RFA)DEVICE

Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.

Also known as: ClosureFast
RFA (ClosureFast)
Roll-in (VenaSeal SCS)DEVICE

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Also known as: VenaSeal Sapheon Closure System, VSCS, Roll-in
Roll-in (VenaSeal SCS)

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Morrison Vein Institute

Scottsdale, Arizona, 85255, United States

Location

GBK Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Radiology Imaging Associates (RIA)

Greenwood Village, Colorado, 80111, United States

Location

Vein Clinics of America

Oakbrook Terrace, Illinois, 60181, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62701, United States

Location

MD Laser Skin & Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Vein Institute of Buffalo

North Tonawanda, New York, 14120, United States

Location

Inovia Vein Specialty Center

Bend, Oregon, 97701, United States

Location

Sentara Vascular Specialist

Virginia Beach, Virginia, 23452, United States

Location

Lake Washington Vascular

Bellevue, Washington, 98004-4623, United States

Location

Related Publications (4)

  • 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.

    PMID: 28411697RESULT

  • 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.

    PMID: 27638993RESULT

  • 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.

    PMID: 29914814DERIVED

  • 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: 25650040DERIVED

Results Point of Contact

Title
Melissa Hasenbank, Clinical Research Director
Organization
Medtronic Endovascular
melissa.hasenbank@medtronic.com
707-525-0111

Study Officials

  • Nick Morrison, MD

    Morrison Vein Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 8, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

April 10, 2017

Last Updated

June 26, 2018

Results First Posted

June 26, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(10)