VeClose Five Year Follow-Up Extension Study

Follow-up of Patients Treated in VeClose Study (Five Years)

The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).

Study Overview

• Status: Completed
• Conditions: Great Saphenous Vein (GSV) With Venous Reflux Disease
• Intervention / Treatment: Device: VenaSeal SCS; Device: ClosureFast Radiofrequency Ablation (RFA); Device: Roll-In (VenaSeal SCS)

Detailed Description

The VeClose Five Year Follow-up Extension Study will continue to assess the safety and efficacy of the VenaSeal Closure System for the long term effect on closure of the great saphenous vein by conducting a follow-up visit at five years post index procedure/enrollment in the VeClose study.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

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
    • 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 Speciality Center
  • Virginia
    • Virginia Beach, Virginia, United States, 23452
      • Sentara Vascular Specialists
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects currently enrolled in both arms of the VeClose Study (NCT01807585) will be assessed for eligibility to enroll in the VeClose Five Year Follow-up Extension Study. All subjects must meet the inclusion criteria and must not meet the exclusion criteria. Assessment of eligibility is based on data available to the investigator at the time of subject enrollment. The subject will be considered to be enrolled in the VeClose Five Year Follow-up Extension Study after the informed consent is signed/dated and all of the study eligibility criteria have been met.

Description

Inclusion Criteria:

1. Enrolled in the VeClose study.
2. Able and willing to complete the required 5 year study visit including Duplex ultrasound exam.
3. Able and willing to provide written informed consent prior to study specific data collection.

Exclusion Criteria:

1. Withdrew consent from the VeClose study.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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 at the time of enrollment into the VeClose study (NCT01807585).	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; 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 to RFA at the time of enrollment into the VeClose study (NCT01807585).	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 for the VeClose study (NCT01807585), a non-randomized cohort of 2 subjects per site (roll-in phase) were enrolled and treated with VenaSeal 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
Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).	Complete closure is defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5cm.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous Clinical Severity Score (VCSS)	Change in Venous Clinical Severity Score (VCSS) at 5 years as compared to baseline data from the VeClose study (NCT01807585). The VCSS is an Investigator assessment of the severity of venous reflux disease, assessing signs and symptoms such as pain, varicose veins, venous edema, skin pigmentation, induration and inflammation. The VCSS score is the sum of responses to 10 questions. Each question has a total possible of 3 points, which are then added for each question. The overall VCSS scores can therefore range from 0 (no venous disease) to 30 (severe venous disease). High scores indicate worse outcomes and "0" is the best possible outcome.	5 years
Aberdeen Varicose Vein Questionnaire (AVVQ)	Change in Aberdeen Varicose Vein Questionnaire (AVVQ) at 5 years as compared to baseline data from the VeClose study (NCT01807585). AVVQ is a disease-specific 13-item questionnaire used to assess the impact of varicose veins on the quality of life, such as pain caused by varicose veins, and need to take painkilling tablets for varicose veins as well as assessing the presence of signs/symptoms such as ankle swelling, purple discoloration and rash/eczema. The total score of AVVQ is the sum of all questions for each leg. Scores range from 0 (no disease) to 100 (maximal disease). High scores indicate worse outcomes and "0" is the best possible outcome.	5 years
Quality of Life survey (EQ-5D)	Change in Quality of Life survey (EQ-5D) at 5 years as compared to baseline data from the VeClose study (NCT01807585). EQ-5D is a short generic quality of life survey that is commonly used outside of the United States for health technology assessments. The "health state today" question provides an overall assessment along a 20-cm visual analog scale (VAS) with a range from 0 ("worst imaginable health state") to 100 ("best imaginable health state").	5 years
CEAP classification ("clinical, etiology, assessment and pathophysiology")	Standardized measure of the degree of venous insufficiency and secondary manifestations of venous disease as measured by the treating physician.	5 years
Satisfaction with Treatment	Satisfaction with Treatment assessment consists of a brief 2-question patient survey rating satisfaction with treatment provided and whether the subject would undergo the assigned treatment again. The number (percent) of subjects on each level of satisfaction are summarized (Very satisfied, Somewhat satisfied, Somewhat dissatisfied, Very dissatisfied). The number (percent) of subjects for the second satisfaction question, "would undergo treatment again" were also summarized by response (Definitely have again, Might have again, Not have again).	5 years
Adverse events (AE) related to the target GSV	AEs related to the GSV will be tabulated and reporting using the MedDRA dictionary, version 16.1.	5 years
Adjunctive procedures performed on the study limb	Details of adjunctive procedures performed on the study limb will be captured on Case Report Forms (CRFs)	5 years

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Nick Morrison, MD, Morrison Vein Institute

Publications and helpful links

General Publications

• 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.
• 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.
• Morrison N, Gibson K, Vasquez M, Weiss R, Jones A. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):978-989. doi: 10.1016/j.jvsv.2019.12.080. Epub 2020 Mar 20.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: GSV
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: CP-1011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO