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周围地塞米松治疗：检查取栓后炎症的减少对急性股腘 DVT 的疗效 (DEXTERITY-AFP)

2026年9月22日 更新者：Mercator MedSystems, Inc.

静脉周围地塞米松治疗：检查取栓后炎症的减少对急性股腘 DVT 的疗效 (DEXTERITY-AFP)

This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for up to 14 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

80

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 爱尔兰
      • Galway、爱尔兰、H91 YR71
        • 完全的
        • Galway University Hospital
  • 美国
    • Arizona
      • Scottsdale、Arizona、美国、85260
        • 招聘中
        • HonorHealth
    • California
      • Orange、California、美国、92868
        • 招聘中
        • Providence St. Joseph Hospital
    • Connecticut
      • Darien、Connecticut、美国、06820
        • 招聘中
        • Vascular Care Connecticut
    • Florida
      • Atlantis、Florida、美国、33462
        • 招聘中
        • HCA Florida JFK Hospital
      • Jacksonville、Florida、美国、32258
        • 完全的
        • Baptist Health
      • Tampa、Florida、美国、33060
        • 招聘中
        • University of South Florida
    • Georgia
      • Atlanta、Georgia、美国、30303
        • 招聘中
        • Grady Memorial Hospital
      • Atlanta、Georgia、美国、30309
        • 招聘中
        • Piedmont Heart Institute
    • Louisiana
      • Houma、Louisiana、美国、70360
        • 招聘中
        • CIS Clinical Research
    • Maryland
      • Hyattsville、Maryland、美国、20782
        • 招聘中
        • Medstar Health Research Institute
    • New Jersey
      • Englewood、New Jersey、美国、07631
        • 招聘中
        • Englewood Health
    • New York
      • Stony Brook、New York、美国、11794
        • 招聘中
        • Stony Brook University Hospital
    • North Carolina
      • Raleigh、North Carolina、美国、27607
        • 招聘中
        • NC Heart and Vascular Research
    • Ohio
      • Columbus、Ohio、美国、43214
        • 完全的
        • OhioHealth Research Institute
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15212
        • 招聘中
        • Allegheny General Hospital
    • Texas
      • Arlington、Texas、美国、76015
        • 招聘中
        • HCA Medical City Arlington
      • Houston、Texas、美国、77004
        • 招聘中
        • HCA Houston Healthcare Medical Center
      • Plano、Texas、美国、75093
        • 招聘中
        • Baylor Scott & White Hospital
    • Virginia
      • Norfolk、Virginia、美国、23452
        • 招聘中
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle、Washington、美国、98133
        • 招聘中
        • UW Medical Center - Northwest
  • 英国
      • London、英国、SE1 7EH
        • 主动，不招人
        • Guy's and St. Thomas Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 89年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Provision of signed and dated informed consent form prior to receiving any non-standard of care, protocol-specific procedures.
  2. Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits and availability for the duration of the study.
  3. Male or female, aged 18 to 89 years.
  4. For females of reproductive potential: use of highly effective contraception (abstinence is acceptable) for at least 1 month prior to study treatment (unless they had given birth within the 1 month prior to study treatment), and agreement to use such a method for at least 30 days after study treatment.
  5. Onset of acute DVT symptoms of 14 days or less prior to initial intervention in the study limb.
  6. Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen.
  7. Post-procedural prescription for at least 28 days low molecular weight heparin followed by therapeutic anticoagulant of investigator's choice for 12 months minimum as part of post-interventional medication regimen.
  8. Minimum of 28 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor) for patients receiving stents.
  9. DVT located in any of the major femoropopliteal veins (common femoral, femoral, and/or popliteal above the tibial plateau), with possible extension downstream into the iliac veins.
  10. Successful recanalization of the target vein with removal of acute thrombus.

Exclusion Criteria:

  1. Current enrollment in another non-registry clinical study of systemic drug therapy or another device study that has not completed its primary endpoint, including prior enrollment in this study. Concurrent enrollment in registry studies of approved devices or drugs are acceptable.
  2. Lack of capability of understanding the nature, significance and implications of the clinical trial.
  3. Body Mass Index between 40 kg/m2 and 45 kg/m2, with significant comorbidity which, in the Investigator's discretion, could impair follow-up or study outcomes.
  4. Body Mass Index > 45 kg/m2.
  5. Non-ambulatory status prior to DVT occurrence.
  6. In the study leg: current established PTS (Villalta ≥ 5 for more than 14 days), current known symptomatic deep venous insufficiency for more than 14 days, or previous symptomatic DVT within the last 365 days.
  7. In the contralateral (non-study) leg: symptomatic DVT that, in the opinion of the operating physician, will require a subsequent open or endovascular surgery in the following 30 days.
  8. In cases with symptoms of limb-threatening circulatory compromise, ankle-brachial index <0.4, absolute ankle pressure <50 mmHg or absolute toe pressure <30 mmHg.
  9. Pulmonary embolism (PE) defined as either massive (systolic blood pressure < 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management of PE. Low-risk PE and/or intermediate low-risk PE can be enrolled.
  10. Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
  11. Allergy or hypersensitivity to any drugs planned for use in the case (including dexamethasone sodium phosphate, iodinated contrast, low molecular-weight heparin, or recombinant tissue plasminogen activator, rtPA, if planned), except for mild-moderate contrast allergies for which steroid pre-medication can be used.
  12. History of, or active heparin-induced thrombocytopenia (HIT).
  13. Hemoglobin < 8.0 g/dl.
  14. INR > 1.6 before starting anticoagulation.
  15. Platelets < 100,000/ml.
  16. Severe renal impairment (estimated glomerular filtration rate < 30 ml/min).
  17. Active bleeding, recent (< 1 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
  18. Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy.
  19. Recent (< 10 days) major surgery, trauma, cardiopulmonary resuscitation, or other invasive procedure which, in the Investigator's discretion, could impair follow-up or study outcomes.
  20. Obstetrical delivery <72 hours prior to procedure.
  21. Hemorrhagic stroke within the last 365 days.
  22. Intracranial/intraspinal bleed within the last 365 days.
  23. Intracranial/intraspinal tumor within the last 365 days.
  24. Intracranial/intraspinal vascular malformation within the last 365 days.
  25. Intracranial/intraspinal aneurysm within the last 365 days.
  26. Active symptomatic COVID-19 infection that, in the Investigator's discretion, could impair follow-up or study outcomes.
  27. Severe hypertension on repeated readings (systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg). This can be treated, and blood pressure must be stable before venous access is obtained (systolic blood pressure <140 mmHg).
  28. Pregnant or breastfeeding.
  29. Life expectancy < 2 years (e.g. due to active cancer).
  30. Major thrombus of the inferior vena cava (IVC) (occlusive or near-occlusive) extending at least one centimeter above the common iliac confluence.
  31. Inability to obtain venous access.
  32. Inability to recanalize the target vein segment with less than 30% residual obstruction due to thrombus.
  33. History of ipsilateral venous stent.
  34. DVT target length intended for drug treatment exceeds 50 cm.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
假比较器：控制
组合产品：Perivascular sham

Saline delivery around target vein segment(s)
实验性的：治疗
组合产品：Perivascular dexamethasone

Dexamethasone delivery around target vein segment(s)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rate of clinically relevant primary patency
大体时间：6 months

Rate of freedom from loss of patency (defined as 100% occlusion of unstented vein or 50% stenosis of stented vein measured by duplex ultrasound or angiogram) with associated symptoms
6 months
Limit the progression to PTS
大体时间：6 months

PTS rate by Villalta score ≥5.
6 months
Rate of freedom from major adverse event (MAE)
大体时间：30 days

Rate of freedom from composite of all-cause death, clinically significant pulmonary embolism, major bleeding, target vessel thrombosis, infection of treatment or insertion site, or AV fistula of treatment site
30 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Mercator MedSystems, Inc.

合作者

National Heart, Lung, and Blood Institute (NHLBI)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年10月29日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2029年2月1日

研究注册日期

首次提交

2021年4月23日

首先提交符合 QC 标准的

2021年4月26日

首次发布 (实际的)

2021年4月28日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CIP0217
  • R44HL160434 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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