VeClose Five Year Follow-Up Extension Study
2019年4月10日 更新者：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).
調査の概要
状態
完了
詳細な説明
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.
研究の種類
観察的
入学 (実際)
114
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Scottsdale、Arizona、アメリカ、85255
- Morrison Vein Institute
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California
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San Diego、California、アメリカ、92121
- GBK Cosmetic Laser Dermatology
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Colorado
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Greenwood Village、Colorado、アメリカ、80111
- Radiology Imaging Associates (RIA)
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Illinois
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Springfield、Illinois、アメリカ、62701
- Prairie Education & Research Cooperative
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Maryland
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Hunt Valley、Maryland、アメリカ、21030
- MD Laser Skin & Vein Institute
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New York
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North Tonawanda、New York、アメリカ、14120
- Vein Institute of Buffalo
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Oregon
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Bend、Oregon、アメリカ、97701
- Inovia Vein Speciality Center
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Virginia
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Virginia Beach、Virginia、アメリカ、23452
- Sentara Vascular Specialists
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Washington
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Bellevue、Washington、アメリカ、98004
- Lake Washington Vascular
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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静脈を閉じるために静脈内に送達される独自の医療用接着剤を使用する、非腫脹性、非熱性、非硬化性の処置。
他の名前：
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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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Covidien ClosureFast システムを使用した GSV の高周波熱アブレーション。
他の名前：
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Venous Clinical Severity Score (VCSS)
時間枠：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)
時間枠：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)
時間枠：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")
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Nick Morrison, MD、Morrison Vein Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年7月1日
一次修了 (実際)
2019年1月1日
研究の完了 (実際)
2019年1月1日
試験登録日
最初に提出
2018年2月28日
QC基準を満たした最初の提出物
2018年2月28日
最初の投稿 (実際)
2018年3月6日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月12日
QC基準を満たした最後の更新が送信されました
2019年4月10日
最終確認日
2019年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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