VeClose Five Year Follow-Up Extension Study

Great Saphenous Vein (GSV) With Venous Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455699
• Other study ID #: CP-1011
• Status: Completed
• Start date: July 2016
• Est. completion date: January 2019

Study information

• Verified date: April 2019
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Great Saphenous Vein (GSV) With Venous Reflux Disease

Intervention

Device:
• VenaSeal SCS
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
• ClosureFast Radiofrequency Ablation (RFA)
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
• Roll-In (VenaSeal SCS)
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Locations

Country	Name	City	State
United States	Lake Washington Vascular	Bellevue	Washington
United States	Inovia Vein Speciality Center	Bend	Oregon
United States	Radiology Imaging Associates (RIA)	Greenwood Village	Colorado
United States	MD Laser Skin & Vein Institute	Hunt Valley	Maryland
United States	Vein Institute of Buffalo	North Tonawanda	New York
United States	GBK Cosmetic Laser Dermatology	San Diego	California
United States	Morrison Vein Institute	Scottsdale	Arizona
United States	Prairie Education & Research Cooperative	Springfield	Illinois
United States	Sentara Vascular Specialists	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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