The Merit WRAPSODY AV Access Efficacy Study (WAVE) (WAVE)
血液透析患者における静脈流出回路の狭窄または閉塞の治療のためのメリット WRAPSODY™ 血管内ステント移植片と経皮的経管的血管形成術を比較する前向き無作為化対照多施設研究。 WAVE研究
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Arizona
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Tempe、Arizona、アメリカ、85281
- Southwest Kidney institute (SKI) Vascular Center
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Tucson、Arizona、アメリカ、85718
- Pima Heart and Vascular
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California
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Orange、California、アメリカ、92868
- St. Joseph Hospital
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Connecticut
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Darien、Connecticut、アメリカ、06820
- Vascular Care Connecticut
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Delaware
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Newark、Delaware、アメリカ、19713
- Nephrology Associates
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Florida
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Jacksonville、Florida、アメリカ、32256
- First Coast Cardiovascular Institute
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Miami、Florida、アメリカ、33169
- Open Access Miami, LLC
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Oscala、Florida、アメリカ、34471
- Leesburg Vascular Access Center & Discovery Medical Research
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Pensacola、Florida、アメリカ、32504
- Coastal Vascular and Interventional
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern Medical Center
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Chicago、Illinois、アメリカ、60559
- Chicago Access Center
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana University Hospital and Methodist Hospital
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Kentucky
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Ashland、Kentucky、アメリカ、41101
- King's Daughters Medical Center
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Massachusetts
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West Roxbury、Massachusetts、アメリカ、02130
- Brigham and Women's Faulkner Hospital
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Michigan
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Flint、Michigan、アメリカ、48507
- Michigan Vascular Access Center
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New Jersey
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Vineland、New Jersey、アメリカ、80360
- Vascular Institute of Atlantic Medical Imaging
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- UNC Health
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Charlotte、North Carolina、アメリカ、28202
- Charlotte Radiology
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Raleigh、North Carolina、アメリカ、27607
- NC Heart and Vascular Research
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Raleigh、North Carolina、アメリカ、27610
- North Carolina Nephrology Raleigh Access
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University Pittsburg Medical Center
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Rhode Island
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Providence、Rhode Island、アメリカ、02906
- Providence Access Center
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South Carolina
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Greenville、South Carolina、アメリカ、29605
- Prisma Health System Upstate
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Texas
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Dallas、Texas、アメリカ、75235
- Renal Disease Research Institute
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Dallas、Texas、アメリカ、75226
- Soltero Cardiovascular Research Center
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Fort Worth、Texas、アメリカ、76104
- PPG Health PA, DBA-Tarrant Vascular
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Houston、Texas、アメリカ、77030
- Houston Methodist Hospital
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Houston、Texas、アメリカ、77008
- Global Kidney Associates
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Katy、Texas、アメリカ、77494
- University of Texas Health - Memorial Hermann Katy Hospital
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Pasadena、Texas、アメリカ、77504
- CDVA
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Plano、Texas、アメリカ、75093
- Dallas Nephrology Associates
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Virginia
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Virginia Beach、Virginia、アメリカ、23507
- Sentara Vascular Specialists
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Birmingham、イギリス、B15 2TH
- Queen Elizabeth Hospital
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Dorchester、イギリス
- Dorset County Hospital
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London、イギリス、E1 1FR
- Royal London Hospital
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Oxford、イギリス、OX3 7LE
- Churchill Hospital
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Stevenage、イギリス、SG1 4AB
- Lister Hospital
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Toronto、カナダ
- Toronto General Hospital
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Brasília、ブラジル
- Instituto Santa Marta De Ensino E Pesquisa
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Recife、ブラジル
- Real Hospital Português de Beneficência em Pernambuco
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Rio de Janeiro、ブラジル
- Hospital Universitário Pedro Ernesto
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São Paulo、ブラジル
- Instituto Dante Pazzanese de Cardiologia
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
説明
包含基準:
- 被験者は書面によるインフォームドコンセントを提供します
- -被験者は男性または女性であり、登録日の年齢は18歳以上です。
- -被験者はすべてのフォローアップ評価を受けることをいとわない。
- -被験者の平均余命は12か月以上です。
- 被験者は慢性血液透析を受けています。
- -被験者は腕に成熟したAVFまたはAVGのいずれかを持っています.
- 標的病変は、新規狭窄または非ステント再狭窄病変を含む。
- 標的病変に50%以上の狭窄がある。
- 標的病変の参照血管径は 5.0 mm から 14.0 mm の間です
除外基準:
- -被験者は、血液透析アクセス部位の既知または疑わしい感染症、全身感染症および/または敗血症を患っています。
- -被験者は、登録前3か月以内に脳卒中の診断を受けています。
- -被験者は登録前60日以内に不安定狭心症または心筋梗塞の病歴があります。
- -被験者は妊娠中、授乳中、または来年中に妊娠する予定です。
- 標的病変はステント/ステントグラフト内にあります。
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：AVF周辺研究治療グループ
WRAPSODY 血管内ステントグラフトによる治療に無作為に割り付けられた被験者
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ステントグラフト留置で治療された標的病変
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|
他の：AVF ペリフェラル コントロール グループ
標準的な経皮経管血管形成術（PTA）による治療に無作為に割り付けられた被験者
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-標準的な経皮経管血管形成術（PTA）で治療された標的病変
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実験的：AVG 吻合
この単群コホートのすべての被験者は、WRAPSODY血管内ステントグラフトによる治療を受けます
|
ステントグラフト留置で治療された標的病変
|
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 |
|---|---|---|
|
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)
時間枠：30 days
|
Percentage of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis).
Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
|
30 days
|
|
Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
時間枠：6 months
|
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 6 Months.
TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Subjects With Target Lesion Primary Patency
時間枠：12 months
|
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 12 Months.
TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
|
12 months
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Subjects With Target Lesion Primary Patency
時間枠：24 months
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Percentage of subjects with Target Lesion Primary Patency (TLPP) at 24 Months.
TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
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24 months
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Subjects With Assisted Target Lesion Primary Patency (aTLPP)
時間枠：6 months
|
Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 6 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up. |
6 months
|
|
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
時間枠：12 months
|
Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 12 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up. |
12 months
|
|
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
時間枠：24 months
|
Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 24 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up. |
24 months
|
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Subjects With Access Circuit Primary Patency (ACPP)
時間枠：6 months
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6 months
|
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Subjects With Access Circuit Primary Patency (ACPP)
時間枠：12 months
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12 months
|
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Subjects With Access Circuit Primary Patency (ACPP)
時間枠：24 months
|
24 months
|
|
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Subjects With Post-Procedure Secondary Patency
時間枠：6 months
|
Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 6 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up. |
6 months
|
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Subjects With Post-Procedure Secondary Patency
時間枠：12 months
|
Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 12 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up. |
12 months
|
|
Subjects With Post-Procedure Secondary Patency
時間枠：24 months
|
Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 24 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up. |
24 months
|
|
Rates of Procedure-related Adverse Events Involving the Access Circuit
時間枠：Index procedure
|
Rates of procedure-related adverse events involving the access circuit at index procedure
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Index procedure
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Rates of Device-related Adverse Events Involving the Access Circuit
時間枠：Index procedure
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Rates of device-related adverse events involving the access circuit at index procedure
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Index procedure
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Rates of Procedure-related Adverse Events Involving the Access Circuit
時間枠：30 days
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Rates of procedure-related adverse events involving the access circuit at 30 days
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30 days
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Rates of Device-related Adverse Events Involving the Access Circuit
時間枠：30 days
|
Rates of device-related adverse events involving the access circuit at 30 days
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30 days
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Rates of Procedure-related Adverse Events Involving the Access Circuit
時間枠：6 months
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Rates of procedure-related adverse events involving the access circuit at 6 months
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6 months
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Rates of Device-related Adverse Events Involving the Access Circuit
時間枠：6 months
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Rates of device-related adverse events involving the access circuit at 6 months
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6 months
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Rates of Procedure-related Adverse Events Involving the Access Circuit
時間枠：12 Months
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Rates of procedure-related adverse events involving the access circuit at 12 months
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12 Months
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Rates of Device-related Adverse Events Involving the Access Circuit
時間枠：12 Months
|
Rates of device-related adverse events involving the access circuit at 12 months
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12 Months
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Rates of Procedure-related Adverse Events Involving the Access Circuit
時間枠：24 Months
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Rates of procedure-related adverse events involving the access circuit at 24 months
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24 Months
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Rates of Device-related Adverse Events Involving the Access Circuit
時間枠：24 Months
|
Rates of device-related adverse events involving the access circuit at 24 months
|
24 Months
|
協力者と研究者
捜査官
- 主任研究者：Robert Jones, MD、The Queen Elizabeth Hospital
- 主任研究者：Mahmood K Razavi, MD、St. Joseph's Hospital, Orange, CA
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。