Great Saphenous Vein (GSV) With Venous Reflux DiseaseNCT03455699
VeClose Five Year Follow-Up Extension Study
An observational study of Great Saphenous Vein (GSV) With Venous Reflux Disease, run by Medtronic Endovascular at 9 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Great Saphenous Vein (GSV) With Venous Reflux Disease
- What is being tested?
- VenaSeal SCS, ClosureFast Radiofrequency Ablation (RFA) and Roll-In (VenaSeal SCS)
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2016to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1. Withdrew consent from the VeClose study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Lake Washington Vascular
Bellevue, Washington, 98004
Inovia Vein Speciality Center
Bend, Oregon, 97701
Radiology Imaging Associates (RIA)
Greenwood Village, Colorado, 80111
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, 21030
Vein Institute of Buffalo
North Tonawanda, New York, 14120
GBK Cosmetic Laser Dermatology
San Diego, California, 92121
Morrison Vein Institute
Scottsdale, Arizona, 85255
Prairie Education & Research Cooperative
Springfield, Illinois, 62701
Sentara Vascular Specialists
Virginia Beach, Virginia, 23452
About this study
Official title: 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).
Read the 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.
- Being tested
- VenaSeal SCS, ClosureFast Radiofrequency Ablation (RFA), Roll-In (VenaSeal SCS)
- Keywords
- GSV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenaSeal SCSDevice
Also called VenaSeal Sapheon Closure System, VSCS
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
ClosureFast Radiofrequency Ablation (RFA)Device
Also called ClosureFast
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
Roll-In (VenaSeal SCS)Device
Also called VenaSeal Sapheon Closure System, VSCS, Roll-in
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: VenaSeal SCS | |
| 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). Receives: Device: ClosureFast Radiofrequency Ablation (RFA) | |
| 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. Receives: Device: Roll-In (VenaSeal SCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study startJul 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Great Saphenous Vein (GSV) With Venous Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nick Morrison, MD, Principal investigator, Morrison Vein Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455699
- Sponsor's protocol ID
- CP-1011
- Status last verified
- Apr 2019
- First submitted
- 28 Feb 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 28411697Kolluri 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.
PubMed 27638993Morrison 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.
PubMed 32205125
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Patients Treated in VeClose Study (Five Years)
- ClinicalTrials.gov ID
- NCT03455699
- Acronym / sponsor ID
- CP-1011
- Keywords
- GSV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: VenaSeal SCS | – | Device: VenaSeal SCSEndovenous 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 | – | Device: 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) | – | Device: 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Withdrew consent from the VeClose study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenaSeal SCSAlso: VenaSeal Sapheon Closure System, VSCSNon-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein. | Device | Experimental: VenaSeal SCS |
| ClosureFast Radiofrequency Ablation (RFA)Also: ClosureFastRadiofrequency thermal ablation of the GSV using the Covidien ClosureFast system. | Device | Active Comparator: RFA |
| Roll-In (VenaSeal SCS)Also: VenaSeal Sapheon Closure System, VSCS, Roll-inNon-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein. | Device | Experimental: Roll-in (VenaSeal SCS) |
Primary outcome
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.
7 secondary outcomes
Venous Clinical Severity Score (VCSS)
Time frame: 5 years
Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: 5 years
Quality of Life survey (EQ-5D)
Time frame: 5 years
CEAP classification ("clinical, etiology, assessment and pathophysiology")
Time frame: 5 years
Satisfaction with Treatment
Time frame: 5 years
Adverse events (AE) related to the target GSV
Time frame: 5 years
Adjunctive procedures performed on the study limb
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Background: PubMed 28411697Morrison 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.
- Background: PubMed 27638993Kolluri 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.
- Derived from this study: PubMed 32205125Morrison 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Morrison, MD principal investigator
Morrison Vein Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Great Saphenous Vein (GSV) With Venous Reflux Disease, run by Medtronic Endovascular at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585). (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03455699, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.