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VeClose Five Year Follow-Up Extension Study

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ClinicalTrials.gov Identifier: NCT03455699
Recruitment Status : Active, not recruiting
First Posted : March 6, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Description
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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).

Condition or disease Intervention/treatment
Great Saphenous Vein (GSV) With Venous Reflux Disease Device: VenaSeal SCS Device: ClosureFast Radiofrequency Ablation (RFA) Device: Roll-In (VenaSeal SCS)

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
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Study Type : Observational
Estimated Enrollment : 205 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
Estimated Study Completion Date : April 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
 Device: VenaSeal SCS
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Other Names:
  • VenaSeal Sapheon Closure System
  • VSCS
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).
 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.
 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:
  • VenaSeal Sapheon Closure System
  • VSCS
  • Roll-in


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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").

  4. 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.

  5. 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).

  6. 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.

  7. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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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
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Nick Morrison, MD Morrison Vein Institute
More Information
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Publications:

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT03455699     History of Changes
Other Study ID Numbers: CP-1011
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medtronic Endovascular:
GSV