- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03455699
VeClose Five Year Follow-Up Extension Study
10. april 2019 opdateret af: Medtronic Endovascular
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).
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
114
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85255
- Morrison Vein Institute
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California
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San Diego, California, Forenede Stater, 92121
- GBK Cosmetic Laser Dermatology
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Colorado
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Greenwood Village, Colorado, Forenede Stater, 80111
- Radiology Imaging Associates (RIA)
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Illinois
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Springfield, Illinois, Forenede Stater, 62701
- Prairie Education & Research Cooperative
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Maryland
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Hunt Valley, Maryland, Forenede Stater, 21030
- MD Laser Skin & Vein Institute
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New York
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North Tonawanda, New York, Forenede Stater, 14120
- Vein Institute of Buffalo
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Oregon
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Bend, Oregon, Forenede Stater, 97701
- Inovia Vein Speciality Center
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Virginia
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Virginia Beach, Virginia, Forenede Stater, 23452
- Sentara Vascular Specialists
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Washington
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Bellevue, Washington, Forenede Stater, 98004
- Lake Washington Vascular
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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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Ikke-tumescerende, ikke-termisk, ikke-skleroserende procedure, der bruger et proprietært medicinsk klæbemiddel leveret endovenøst til at lukke venen.
Andre navne:
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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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Radiofrekvens termisk ablation af GSV ved hjælp af Covidien ClosureFast-systemet.
Andre navne:
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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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Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).
Tidsramme: 5 years
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Complete closure is defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5cm.
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5 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Venous Clinical Severity Score (VCSS)
Tidsramme: 5 years
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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.
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5 years
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Aberdeen Varicose Vein Questionnaire (AVVQ)
Tidsramme: 5 years
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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.
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5 years
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Quality of Life survey (EQ-5D)
Tidsramme: 5 years
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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").
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5 years
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CEAP classification ("clinical, etiology, assessment and pathophysiology")
Tidsramme: 5 years
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Standardized measure of the degree of venous insufficiency and secondary manifestations of venous disease as measured by the treating physician.
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5 years
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Satisfaction with Treatment
Tidsramme: 5 years
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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).
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5 years
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Adverse events (AE) related to the target GSV
Tidsramme: 5 years
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AEs related to the GSV will be tabulated and reporting using the MedDRA dictionary, version 16.1.
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5 years
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Adjunctive procedures performed on the study limb
Tidsramme: 5 years
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Details of adjunctive procedures performed on the study limb will be captured on Case Report Forms (CRFs)
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5 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Nick Morrison, MD, Morrison Vein Institute
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2016
Primær færdiggørelse (Faktiske)
1. januar 2019
Studieafslutning (Faktiske)
1. januar 2019
Datoer for studieregistrering
Først indsendt
28. februar 2018
Først indsendt, der opfyldte QC-kriterier
28. februar 2018
Først opslået (Faktiske)
6. marts 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CP-1011
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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