Clinical trial NCT03455699: VeClose Five Year Follow-Up Extension Study
Official title: Follow-up of Patients Treated in VeClose Study (Five Years)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Great Saphenous Vein (GSV) With Venous Reflux Disease
Keywords: GSV
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 114
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).
timeFrame: 5 years
Secondary outcomes:
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 5 years
measure: Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: 5 years
measure: Quality of Life survey (EQ-5D)
timeFrame: 5 years
measure: CEAP classification ("clinical, etiology, assessment and pathophysiology")
timeFrame: 5 years
measure: Satisfaction with Treatment
timeFrame: 5 years
measure: Adverse events (AE) related to the target GSV
timeFrame: 5 years
measure: Adjunctive procedures performed on the study limb
timeFrame: 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Morrison Vein Institute
state: Arizona
city: San Diego
country: United States
facility: GBK Cosmetic Laser Dermatology
state: California
city: Greenwood Village
country: United States
facility: Radiology Imaging Associates (RIA)
state: Colorado
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Hunt Valley
country: United States
facility: MD Laser Skin & Vein Institute
state: Maryland
city: North Tonawanda
country: United States
facility: Vein Institute of Buffalo
state: New York
city: Bend
country: United States
facility: Inovia Vein Speciality Center
state: Oregon
city: Virginia Beach
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Bellevue
country: United States
facility: Lake Washington Vascular
state: Washington
Study officials:
affiliation: Morrison Vein Institute
name: Nick Morrison, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.