정맥성 다리 궤양에 대한 혈관내 초음파 유도 중재술(IGuideU) (IGuideU)
정맥성 하지 궤양에 대한 혈관내 초음파 유도 중재술
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).
연구 개요
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Rhine-Westphalia
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Arnsberg, North Rhine-Westphalia, 독일, 59755
- Klinikum Hochsauerland GmbH
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Connecticut
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Darien, Connecticut, 미국, 06820
- Vascular Care Connecticut
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Florida
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Winter Park, Florida, 미국, 32792
- Florida Cardiology, P.A.
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Illinois
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Chicago, Illinois, 미국, 60208
- Northwestern
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Louisiana
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Houma, Louisiana, 미국, 70394
- Cardiovascular Institute of the South
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Lake Charles, Louisiana, 미국, 70601
- Vein Center of Southwest Louisiana
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New Jersey
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Englewood, New Jersey, 미국, 07631
- Englewood Hospital and Medical Center
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New York
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New York, New York, 미국, 10016
- NYU Langone Health
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North Carolina
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Charlotte, North Carolina, 미국, 28210
- Atrium Health
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Hampstead, 영국
- Royal Free London NHS Foundation Trust
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London, 영국
- Guys and St. Thomas' Hospital
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London
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Harrow, London, 영국, HA1 3UJ
- Northwick Park Hospital
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Dijon, 프랑스, 77908
- C.H.U. Dijon
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Alsace
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Strasbourg, Alsace, 프랑스, 67000
- CHU Strasbourg
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Bourbonnais
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Vichy, Bourbonnais, 프랑스, 03200
- CH Vichy
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New South Wales
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Wollongong, New South Wales, 호주, 2500
- Wollongong Hospital
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Western Australia
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Perth, Western Australia, 호주, 6000
- Royal Perth Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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. |
|
다른: Deferred Interrogation Arm
Deferred Interrogation Guidelines for this study are as follows: Mandate: • Continued compression therapy/stockings as prescribed. Allow:
Prohibit:
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Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group
기간: 3 months
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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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Stephen Black, MD, St. Thomas and Guys Hospital
- 수석 연구원: Paul Gagne, MD, Vascular Care CT, PLLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IGT_IGD_VLU_2020_10876
- 200202 (기타 식별자: IGTD Protocol no.)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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