VeClose Five Year Follow-Up Extension Study

Completed

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

• Registration Number: NCT03455699
• Lead Sponsor: Medtronic Endovascular

Brief Summary

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).

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-06
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: VenaSeal SCS	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).
Active Comparator: RFA	ClosureFast Radiofrequency Ablation (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).
Experimental: Roll-in (VenaSeal SCS)	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.

Primary Outcome Measures

Name	Time	Method
Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).	5 years	Complete closure is defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5cm.

Secondary Outcome Measures

Name	Time	Method
Aberdeen Varicose Vein Questionnaire (AVVQ)	5 years	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.
CEAP classification ("clinical, etiology, assessment and pathophysiology")	5 years	Standardized measure of the degree of venous insufficiency and secondary manifestations of venous disease as measured by the treating physician.
Satisfaction with Treatment	5 years	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).
Adverse events (AE) related to the target GSV	5 years	AEs related to the GSV will be tabulated and reporting using the MedDRA dictionary, version 16.1.
Adjunctive procedures performed on the study limb	5 years	Details of adjunctive procedures performed on the study limb will be captured on Case Report Forms (CRFs)
Venous Clinical Severity Score (VCSS)	5 years	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.
Quality of Life survey (EQ-5D)	5 years	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").

Trial Locations

Locations (9)

Morrison Vein Institute; 🇺🇸 Scottsdale, Arizona, United States

Radiology Imaging Associates (RIA); 🇺🇸 Greenwood Village, Colorado, United States

GBK Cosmetic Laser Dermatology; 🇺🇸 San Diego, California, United States

Prairie Education & Research Cooperative; 🇺🇸 Springfield, Illinois, United States

Vein Institute of Buffalo; 🇺🇸 North Tonawanda, New York, United States

MD Laser Skin & Vein Institute; 🇺🇸 Hunt Valley, Maryland, United States

Sentara Vascular Specialists; 🇺🇸 Virginia Beach, Virginia, United States

Inovia Vein Speciality Center; 🇺🇸 Bend, Oregon, United States

Lake Washington Vascular; 🇺🇸 Bellevue, Washington, United States