DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis

Официальное название

DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis

Обзор

This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.

Подробное описание

The study will compare the clinical outcomes of patients treated with an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of symptomatic unilateral iliofemoral DVT. Approximately 300 subjects will be enrolled and randomized. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be randomized (1:1, ClotTriever Intervention Arm or Conservative Medical Management Arm).

Вмешательства

• Устройство ClotTriever System
  Mechanical thrombectomy
• Препарат Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
  Anticoagulants are a group of medications that decrease your blood's ability to clot.

Первичные конечные точки

• Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: [Срок оценки: 180 Days (+-14 Days)]

Вторичные конечные точки (2)

• Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: [Срок оценки: 10 Days (+- 3 Days)]
• Assessment of PTS Severity: [Срок оценки: 180 Days (+-14 Days)]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Proximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac veins, alone or in combination
• Symptom onset within 12 weeks of enrollment in the study
• Significant symptoms, as defined by a Villalta score > 9
• Willing and able to provide informed consent

Критерии исключения

• Bilateral iliofemoral DVT
• Prior venous stent in the target venous segment
• IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
• IVC filter in place at the time of enrollment
• Limb-threatening circulatory compromise (e.g., phlegmasia)
• Clot in transit including IVC thrombus presenting as extension of >2cm into the IVC from the CIV
• Symptomatic PE with right heart strain where the physician judges that a DVT intervention is inappropriate at this time.
• Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement
• Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
• Severe allergy to iodinated contrast agents that cannot be mitigated
• Hemoglobin < 8.0 g/dL, INR > 1.7 before warfarin was started, or platelets < 50,000/µl which cannot be corrected prior to enrollment
• Severe renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on dialysis
• Inability to provide therapeutic anticoagulation per Investigator discretion
• Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)
• Recently (< 30 days) had DVT interventional procedure
• Subject is participating in another study that may interfere with this study
• Life expectancy < 6 months or chronic non-ambulatory status
• Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of ClotTriever per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments)
• Subject has previously completed or withdrawn from this study
• Patient unwilling or unable to conduct the follow up visits per protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 48 центров

• Honor Health — Scottsdale
• Pima Heart and Vascular — Tucson
• UCI Medical Center — Orange
• Vascular and Interventional Specialists of Orange County — Orange
• Huntington Health — Pasadena
• University Of Colorado — Denver
• Yale University — New Haven
• MedStar Health Research Institution — Washington D.C.
• … и ещё 40 центров

Германия · 7 центров

• Universitätsklinikum Tübingen — Tübingen
• MVZ CCB Frankfurt und Main-Taunus GbR — Frankfurt am Main
• Klinikum Hochsauerland GmbH — Arnsberg
• Universität Leipzig — Leipzig
• Charité - Universitätsmedizin Berlin — Berlin
• Universitätsklinikum Augsburg — Augsburg
• Universitätsklinikum Heidelberg — Heidelberg

Великобритания · 4 центра

• GSST London/St Thomas — London
• Imperial College — London
• Freeman Hospital Newcastle upon Tyne — Newcastle upon Tyne
• Oxford - John Radcliffe — Oxford

Швейцария · 3 центра

• Kantonsspital Baden — Baden
• Inselspital, Universitätsspital Bern — Bern
• Luzerner Kantonsspital — Lucerne

Австрия · 1 центр

• Vienna General Hospital (AKH Wien) — Vienna

Финляндия · 1 центр

• Helsinki University Hospital — Helsinki

Публикации

• Abramowitz SD, Marko X, D'Souza D, Noor S, Pereira K, Silver MJ, Rosenberg SP, Markovitz CD, Tu T, Weinberg I, Black S. Rationale and design of the DEFIANCE study: A randomized controlled trial of mechanical thrombectomy versus anticoagulation alone for iliofemoral deep vein thrombosis. Am Heart J. 2025 Mar;281:92-102. doi: 10.1016/j.ahj.2024.10.016. Epub 2024 Nov 3. PMID 39491572
• Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2. PMID 39968829

Идентификаторы

NCT: NCT05701917 · 22-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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