VeClose Five Year Follow-Up Extension Study
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ClinicalTrials.gov Identifier: NCT03455699 |
Recruitment Status :
Completed
First Posted : March 6, 2018
Last Update Posted : April 12, 2019
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Condition or disease | Intervention/treatment |
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Great Saphenous Vein (GSV) With Venous Reflux Disease | Device: VenaSeal SCS Device: ClosureFast Radiofrequency Ablation (RFA) Device: Roll-In (VenaSeal SCS) |
Study Type : | Observational |
Actual Enrollment : | 114 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Follow-up of Patients Treated in VeClose Study (Five Years) |
Actual Study Start Date : | July 2016 |
Actual Primary Completion Date : | January 2019 |
Actual Study Completion Date : | January 2019 |
Group/Cohort | Intervention/treatment |
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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).
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Device: VenaSeal SCS
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Other Names:
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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).
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Device: ClosureFast Radiofrequency Ablation (RFA)
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
Other Name: 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.
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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:
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- Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585). [ Time Frame: 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.
- Venous Clinical Severity Score (VCSS) [ Time Frame: 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.
- Aberdeen Varicose Vein Questionnaire (AVVQ) [ Time Frame: 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.
- Quality of Life survey (EQ-5D) [ Time Frame: 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").
- CEAP classification ("clinical, etiology, assessment and pathophysiology") [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 years ]Details of adjunctive procedures performed on the study limb will be captured on Case Report Forms (CRFs)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Enrolled in the VeClose study.
- Able and willing to complete the required 5 year study visit including Duplex ultrasound exam.
- Able and willing to provide written informed consent prior to study specific data collection.
Exclusion Criteria:
1. Withdrew consent from the VeClose study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455699
United States, Arizona | |
Morrison Vein Institute | |
Scottsdale, Arizona, United States, 85255 | |
United States, California | |
GBK Cosmetic Laser Dermatology | |
San Diego, California, United States, 92121 | |
United States, Colorado | |
Radiology Imaging Associates (RIA) | |
Greenwood Village, Colorado, United States, 80111 | |
United States, Illinois | |
Prairie Education & Research Cooperative | |
Springfield, Illinois, United States, 62701 | |
United States, Maryland | |
MD Laser Skin & Vein Institute | |
Hunt Valley, Maryland, United States, 21030 | |
United States, New York | |
Vein Institute of Buffalo | |
North Tonawanda, New York, United States, 14120 | |
United States, Oregon | |
Inovia Vein Speciality Center | |
Bend, Oregon, United States, 97701 | |
United States, Virginia | |
Sentara Vascular Specialists | |
Virginia Beach, Virginia, United States, 23452 | |
United States, Washington | |
Lake Washington Vascular | |
Bellevue, Washington, United States, 98004 |
Principal Investigator: | Nick Morrison, MD | Morrison Vein Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medtronic Endovascular |
ClinicalTrials.gov Identifier: | NCT03455699 |
Other Study ID Numbers: |
CP-1011 |
First Posted: | March 6, 2018 Key Record Dates |
Last Update Posted: | April 12, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
GSV |
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |