静脈性下肢潰瘍に対する血管内超音波ガイド下インターベンション (IGuideU) (IGuideU)
静脈性下肢潰瘍に対する血管内超音波ガイド下インターベンション
This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will result in a more accurate diagnosis of deep vein occlusion (DVO), will guide optimal therapy, and will provide better clinical outcomes with reduced cost of care for patients presenting with persistent venous leg ulcers (VLUs).
調査の概要
詳細な説明
This study will be conducted in 266 subjects presenting with venous ulcers that have previously undergone treatment for superficial of and/or perforator venous disease, if clinically indicated, followed by at least 3 months of prescribed compression therapy prior to screening.
There are 6 study visits for each subject that will be completed over a period lasting approximately 24 months. Subjects will undergo a baseline/screening assessment (visit 1) followed by an interrogation procedure (visit 2) if the subject is enrolled into the interrogation arm. If the subject is randomized to the deferred interrogation arm, he/she will have a hospital/office visit in lieu of the interrogation procedure, which will be considered visit 2. For statistical purposes, the wound assessment performed at the index procedure/hospital visit will be considered the baseline measurement. 30±14 days and 90±14 days after Visit 2, the subject will return to the office for a 1- and 3-month follow-up visit, respectively. The subjects will return at 6- and 12-months post-index procedure/Visit 2 for follow-up assessments. The follow-up period for this study will be approximately 24 months, with a phone call only at 24-months post-index procedure/visit 2.
The clinical study has a planned enrollment period of 36 months and a planned study duration period of 5.17 years
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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Connecticut
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Darien、Connecticut、アメリカ、06820
- Vascular Care Connecticut
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Florida
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Winter Park、Florida、アメリカ、32792
- Florida Cardiology, P.A.
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Illinois
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Chicago、Illinois、アメリカ、60208
- Northwestern
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Louisiana
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Houma、Louisiana、アメリカ、70394
- Cardiovascular Institute of the South
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Lake Charles、Louisiana、アメリカ、70601
- Vein Center of Southwest Louisiana
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New Jersey
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Englewood、New Jersey、アメリカ、07631
- Englewood Hospital and Medical Center
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New York
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New York、New York、アメリカ、10016
- NYU Langone Health
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North Carolina
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Charlotte、North Carolina、アメリカ、28210
- Atrium Health
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Hampstead、イギリス
- Royal Free London NHS Foundation Trust
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London、イギリス
- Guys and St. Thomas' Hospital
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London
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Harrow、London、イギリス、HA1 3UJ
- Northwick Park Hospital
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New South Wales
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Wollongong、New South Wales、オーストラリア、2500
- Wollongong Hospital
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Western Australia
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Perth、Western Australia、オーストラリア、6000
- Royal Perth Hospital
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North Rhine-Westphalia
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Arnsberg、North Rhine-Westphalia、ドイツ、59755
- Klinikum Hochsauerland GmbH
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Dijon、フランス、77908
- C.H.U. Dijon
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Alsace
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Strasbourg、Alsace、フランス、67000
- CHU Strasbourg
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Bourbonnais
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Vichy、Bourbonnais、フランス、03200
- CH Vichy
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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
受講資格のある性別
説明
Inclusion Criteria:
- Be between 18 and 85 years of age.
- Able and willing to participate and comply with the protocol, including the defined follow-up schedule, by signing an Institutional Review Board (IRB) or Ethics Committee approved informed consent form.
- Active venous leg ulcer (CEAP C6).
- Previously completed treatment for clinically significant reflux in the superficial and/or perforator venous system of the target limb at least 3 months prior to enrollment, if clinically indicated.
- Completed at least 3 months of prescribed compression therapy after any ablation.
- Palpable dorsalis pedis or posterior tibial artery (DP/PT) pulses at ipsilateral foot or ankle brachial index (ABI) ≥0.8.
- Be able to ambulate unassisted or with non-motorized assistive devices.
- Current VLU present ≤48 months.
Exclusion Criteria:
- Patient is known pregnant or breast-feeding or planning to become pregnant in the following year.
- If antiplatelet and anticoagulation therapy cannot be tolerated.
- Previous venous stent implantation involving the target limb, target lesion, or inferior vena cava.
- Previous venovenous bypass surgery involving the target limb.
- Previous endovascular recanalization of the target lesion segment.
- Known metal allergy precluding stent implantation.
- Known or suspected to have inadequate inflow to support stent patency in the target limb.
- Active cancer diagnosis.
- Known positive test for COVID-19 (Sars-CoV-2) within the last 2 weeks and actively symptomatic.
- Known or suspected venous outflow obstruction caused by tumor compression/encasement with or without thrombus.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Known renal dysfunction (defined as eGFR <30mL/min/1.73m2) that would preclude adequate contrast usage.
- Diagnosed with right heart failure/pulmonary hypertension.
- Has known clinically significant abnormal platelet count outside laboratory reference ranges.
- Has known clinically significant abnormal white blood cell count (WBC), fever, sepsis or positive blood culture.
- Organ transplant requiring immunosuppressant therapy.
- Unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 3 months.
- Subjects with an active diagnosis of osteomyelitis of the ipsilateral limb.
- Previous or planned surgical or catheter-based procedure on index leg within 30 days before or 30 days after the index procedure.
- Active participation in another investigational drug or device study.
- Subject has any condition, which, in the opinion of the investigator, precludes the subject from participation.
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：診断
- 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 |
|---|---|
|
他の：Interrogation Arm
patients will first be evaluated with MPV (limited to 3 views). The prescribed course of treatment based on the MPV results will be documented and patients will then be evaluated using IVUS. A treatment plan based on IVUS results will be compared with the MPV guided treatment plan and any differences will be documented. Any patients determined to still require venous stenting based on IVUS results will be stented accordingly using IVUS to guide stent placement. |
Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan. |
|
他の：Deferred Interrogation Arm
Deferred Interrogation Guidelines for this study are as follows: Mandate: • Continued compression therapy/stockings as prescribed. Allow:
Prohibit:
|
Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed. |
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 |
|---|---|---|
|
Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group
時間枠：3 months
|
Rate of detection and difference in complete ulcer healing between the interrogation group and the deferred interrogation group at 3 months. Complete ulcer healing is defined by 100% epithelialization of the venous ulcer. Healing will not be assumed for any area of the wound where a scab is present. |
3 months
|
協力者と研究者
捜査官
- 主任研究者：Stephen Black, MD、St. Thomas and Guys Hospital
- 主任研究者：Paul Gagne, MD、Vascular Care CT, PLLC
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
本研究に関する用語
その他の研究ID番号
- IGT_IGD_VLU_2020_10876
- 200202 (その他の識別子：IGTD Protocol no.)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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