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THOR IDE 研究 (THOR)

2026年11月2日 更新者：Philips Clinical & Medical Affairs Global

The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).

The main question[s] it aims to answer are:

  • Is the Thor system safe in treating these lesions
  • Does the Thor system work to treat these lesions

Participants will:

  • Receive treatment with the Thor system
  • Have follow-up visits at Discharge, 30 days, 6 months, and 12 months

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Up to 30 sites in the U.S. will be selected to do this study.

Patients with pain in their legs when walking and/or resting that is due to lack of blood flow to their legs may be able to join the study. To join the study patients must also have blockages in their leg arteries that meet the study criteria.

Before the Thor procedure, patients will have a screening visit that includes a review of their medical records, questions about their medical history and medications taken for blood thinning or circulation, a physical examination of their legs, a test to check the blood flow in their legs (by checking arm and leg blood pressures), blood tests, and a pregnancy test if they are a female able to have children. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

All patients in the study will have treatment with the Thor system. There is no "control group" (a group of patients that receives only standard treatment or receives no treatment at all) in this study. During the procedure, the doctor will take x-ray pictures of the leg arteries. They may also use other treatments such as angioplasty balloons, drug-coated balloons, stents, and filters that collect blood clots, if needed.

Patients treated with the Thor system will be watched until they are ready to go home or up to 24 hours after the procedure if they do not go home right away. Before they go home they will have a test to check the blood flow to their legs (by checking arm and leg blood pressures) and be checked for any adverse events.

Patients will return for visits at 30 days, 6 months, and 12 months after the Thor procedure. At these visits patients will be asked questions about their medical history and medications taken for blood thinning or circulation, have a physical examination of their legs, have a test to check the blood flow in their treated leg (by checking arm and leg blood pressures), have an ultrasound of their treated leg, and be checked for any adverse events. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

It will take up to 24 months (2 years) to enroll all of the patients in the study. Patients who join the study will be in the study for about 12 months (1 year) and will have all of the visits with their doctor that they would normally have for their PAD.

研究类型

介入性

注册 (估计的)

155

阶段

  • 不适用

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

研究联系人备份

学习地点

  • 美国
    • California
      • St. Helena、California、美国、94574
        • 撤销
        • St. Helena Hospital
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • Rocky Mountain Regional VA Medical Center
        • 首席研究员：
          • Bilal Aijaz, MD
        • 接触：
        • 副研究员：
          • Stephen Waldo, MD
        • 接触：
    • Florida
      • Bradenton、Florida、美国、34205
      • Tallahassee、Florida、美国、32308
        • 招聘中
        • Tallahassee Research Institute
        • 首席研究员：
          • William Dixon
        • 接触：
        • 接触：
        • 副研究员：
          • John Katopodis
      • Winter Park、Florida、美国、32792
        • 招聘中
        • Guardian Research Organization
        • 首席研究员：
          • Ashish Gupta, MD
        • 接触：
        • 副研究员：
          • Sandeep Bajaj
        • 接触：
          • Tiffany King
    • Iowa
      • Davenport、Iowa、美国、52807
    • Louisiana
      • Houma、Louisiana、美国、70360
        • 招聘中
        • Cardiovascular Institute of the South
        • 首席研究员：
          • Craig Walker, MD
        • 副研究员：
          • Matthew Finn, MD
        • 副研究员：
          • Pradeep Nair, MD
        • 接触：
        • 接触：
        • 副研究员：
          • McCall Walker, MD
      • Lafayette、Louisiana、美国、70503
        • 招聘中
        • Cardiovascular Institute of the South
        • 首席研究员：
          • Ankur Lodha, MD
        • 接触：
        • 副研究员：
          • Amit Amin, MD
        • 副研究员：
          • David Tadin, MD
    • Maine
      • Portland、Maine、美国、04106
        • 招聘中
        • The Vascular Care Group
        • 副研究员：
          • Todd Lancaster, MD
        • 副研究员：
          • Daniel Gorin, MD
        • 副研究员：
          • Christopher Kwolek, MD
        • 接触：
        • 首席研究员：
          • Nathan Aranson, MD
    • Massachusetts
      • Fall River、Massachusetts、美国、02720
        • 招聘中
        • Southcoast Hospitals/Charlton Memorial Hospital
        • 首席研究员：
          • Richard Pin, MD
        • 接触：
        • 副研究员：
          • Mark Perry, MD
        • 副研究员：
          • Brandon Sumpio, MD
      • Leominster、Massachusetts、美国、04153
        • 主动，不招人
        • Vascular Breakthroughs
    • Michigan
      • Detroit、Michigan、美国、48202
        • 招聘中
        • Henry Ford Hospital
        • 副研究员：
          • Pedro Villablanca, MD
        • 副研究员：
          • Khaldoon Alaswad, MD
        • 接触：
        • 副研究员：
          • Gerald Koenig, MD
        • 副研究员：
          • Vikas Aggarwal, MD
        • 副研究员：
          • Mohammad Alqarqaz, MD
        • 副研究员：
          • Herbert Aronow, MD
        • 首席研究员：
          • Kyle Markel, MD
        • 接触：
      • Detroit、Michigan、美国、22201
        • 招聘中
        • Henry Ford St John Hospital
        • 接触：
        • 首席研究员：
          • Thomas Davis, Dr
        • 接触：
    • New Jersey
      • Browns Mills、New Jersey、美国、08015
        • 招聘中
        • Deborah Heart and Lung Center
        • 首席研究员：
          • Richard Kovach, MD
        • 接触：
        • 接触：
        • 副研究员：
          • Gregory Domer, MD
      • New Brunswick、New Jersey、美国、08901
        • 招聘中
        • Heart and Vascular Institute of Central Jersey
        • 首席研究员：
          • Ramzan Zakir, MD
        • 接触：
      • Vineland、New Jersey、美国、08360
        • 招聘中
        • Atlantic Medical Imaging of New jersey
        • 首席研究员：
          • Micah Watts, MD
        • 接触：
        • 接触：
        • 副研究员：
          • Nicholas Petruzzi, MD
        • 副研究员：
          • Ramkrishna Patel, MD
    • New York
      • New York、New York、美国、10029
        • 招聘中
        • Mount Sinai Hospital
        • 首席研究员：
          • Prakash Krishnan, MD
        • 副研究员：
          • David Song, MD
        • 接触：
        • 副研究员：
          • Vishal Kapur, MD
        • 副研究员：
          • Raman Sharma
        • 接触：
      • New York、New York、美国、10029
        • 招聘中
        • New York Presbyterian Hospital/Columbia University Irving Medical Center
        • 接触：
        • 首席研究员：
          • Virendra Patel, MD
        • 副研究员：
          • Thomas O'Donnell, MD
        • 副研究员：
          • Nicholas Morrissey
        • 副研究员：
          • Danielle Bajakian
        • 接触：
    • North Carolina
      • Cary、North Carolina、美国、27518
        • 招聘中
        • Vascular Solutions of North Carolina
        • 接触：
        • 接触：
        • 首席研究员：
          • Sid Rao, MD
    • Ohio
      • Fairborn、Ohio、美国、45324
        • 招聘中
        • Premier Cardiovascular Institute
        • 首席研究员：
          • Sagger Mawri, MD
        • 副研究员：
          • James Pan, MD
        • 接触：
        • 接触：
    • Oklahoma
      • Bartlesville、Oklahoma、美国、74006
        • 招聘中
        • Ascension St. John
        • 接触：
        • 首席研究员：
          • Anderson Merhle, MD
        • 副研究员：
          • Michael Megaly, MD
        • 接触：
          • 电话号码：918.332.3616
    • Pennsylvania
      • Mechanicsburg、Pennsylvania、美国、17050
        • 招聘中
        • UPMC
        • 接触：
        • 首席研究员：
          • William Bachinsky, Dr
        • 接触：
      • Philadelphia、Pennsylvania、美国、19104
        • 招聘中
        • Hospital of the University of Pennsylvania
        • 接触：
        • 首席研究员：
          • Elizabeth Genovese, MD
        • 副研究员：
          • Shang Loh, MD
        • 副研究员：
          • Alexander Fairman, MD
        • 副研究员：
          • Douglas Troutman, MD
      • Wynnewood、Pennsylvania、美国、19096
        • 招聘中
        • Lankenau Institute for Medical Research
        • 接触：
        • 首席研究员：
          • Antonis Pratsos, MD
        • 副研究员：
          • Manju Jayanna, MD
        • 副研究员：
          • Sarang Mangalmurti, MD
        • 接触：
    • Rhode Island
      • Providence、Rhode Island、美国、02905
        • 招聘中
        • The Miriam Hospital
        • 首席研究员：
          • Peter Soukas, MD
        • 接触：
        • 副研究员：
          • Pieter de Klerk, MD
    • Tennessee
      • Chattanooga、Tennessee、美国、37421
        • 招聘中
        • Vascular Institute of Chattanooga
        • 接触：
        • 副研究员：
          • William Harris, DO
        • 首席研究员：
          • Chris LeSar, MD
    • Texas
      • Dallas、Texas、美国、75390
      • Plano、Texas、美国、75093
        • 招聘中
        • Baylor, Scott & White, The Heart Hospital
        • 首席研究员：
          • Sameh Sayfo, MD
        • 副研究员：
          • Chadi Dib, MD
        • 接触：
        • 接触：
        • 副研究员：
          • Tony Das, MD
    • Virginia
      • Norfolk、Virginia、美国、23507
        • 招聘中
        • Sentara Health Research Center
        • 首席研究员：
          • David Dexter, MD
        • 接触：
        • 副研究员：
          • Animesh Rathore, MD
        • 副研究员：
          • Priyam Vyas, MD

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 及以上 (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:

  • Patient age is ≥18 years
  • Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form
  • Patient is able to walk unassisted or with non-motorized assistive devices
  • Patient has PAD with documented Rutherford Class 2-4 of the target limb
  • Anticipated life expectancy >12 months, in the opinion of the investigator at the time of enrollment.

Angiographic Inclusion Criteria:

  • Patient has de novo atherosclerotic disease of the native SFA and/or the popliteal arteries
  • Target lesion has ≥70% diameter stenosis by investigator via visual assessment
  • Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions.
  • Chronic total occlusion lesion length is <100mm of the total ≤150mm target lesion
  • Minimum reference vessel diameter (RVD) 4.0mm by visual estimate
  • Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations
  • At least one patent tibial vessel (defined as <50% stenosis) with runoff to the foot
  • Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria

Exclusion Criteria:

  • Patient has active infection requiring antibiotic therapy
  • Stenting planned within the target lesion
  • Known positive for COVID-19 within the last 2 weeks and actively symptomatic
  • Pregnant (positive pregnancy test) or currently breast feeding
  • Evidence of Acute Limb Ischemia in the target limb within 7 days prior to procedure
  • Cerebrovascular accident (CVA) <60 days prior to procedure
  • Myocardial infarction <60 days prior to procedure
  • History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening
  • Known contraindication to aspirin, or antiplatelet/anti-coagulant therapies required for procedure/follow-up
  • Known allergy to contrast media that cannot adequately be premedicated prior to study procedure
  • History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS)
  • Serum creatinine ≥2.5mg/dL (unless dialysis-dependent) tested within 30 days prior to procedure
  • Planned lower limb major amputation (above the ankle)
  • Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned on target limb for within 30 days following index procedure, with the exception of diagnostic angiography
  • Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study
  • The use of specialty balloons, re-entry or additional atherectomy devices is required for treatment of the target lesion.

Angiographic Exclusion Criteria:

  • Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
  • Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target site at the time of the index procedure.

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Thor Treatment

Treatment with the Thor system
设备：Thor laser atherectomy

Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system

其他名称：
  • 雷神钙修饰

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
Freedom from Major Adverse Events (MAEs)
大体时间：30 Days

Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
30 Days
Procedural Success
大体时间：At completion of the procedure

Defined as residual diameter stenosis ≤50% at the end of the procedure as determined by angiographic core lab
At completion of the procedure

次要结果测量

结果测量
措施说明
大体时间
Target lesion patency, 30 days
大体时间：30 days

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
30 days
Target lesion patency, 6 months
大体时间：6 months

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
6 months
Target lesion patency, 12 months
大体时间：12 months

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
12 months
Clinically-driven target lesion revascularization
大体时间：Through 12 months

Defined as repeat revascularization procedure of the target lesion if PSVR is ≥2.5 by DUS or if angiography shows a percent diameter stenosis >50% and there are worsening clinical symptoms, worsening Rutherford Clinical Category or ABI that is clearly referable to the target lesion.
Through 12 months
Technical success
大体时间：Peri-procedural

Defined as the ability to deliver the Thor system and achieve residual diameter stenosis ≤50% after treatment with Thor and prior to adjunctive PTA, as confirmed by independent core laboratory assessments of angiographic images
Peri-procedural
Frequency of peri-procedural adverse events
大体时间：Within 24 hours of the procedure

Defined as frequency of adverse events related to the investigational device (Thor system)
Within 24 hours of the procedure
Adjunctive devices used with the Thor system
大体时间：Peri-procedural

Defined as the use of other devices including angioplasty balloons, drug coated balloons, bailout stents, embolic filters
Peri-procedural
Target Limb Ankle-Brachial Index (ABI) change, Discharge
大体时间：Discharge or up to 24 hours after the procedure

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at discharge compared to the baseline (Screening) value
Discharge or up to 24 hours after the procedure
Target Limb Ankle-Brachial Index (ABI) change, 30 days
大体时间：30 days

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 30 days compared to the baseline (Screening) value
30 days
Target Limb Ankle-Brachial Index (ABI) change, 6 months
大体时间：6 months

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 6 months compared to the baseline (Screening) value
6 months
Target Limb Ankle-Brachial Index (ABI) change, 12 months
大体时间：12 months

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 12 months compared to the baseline (Screening) value
12 months
Rutherford Classification change, 30 days
大体时间：30 days

Defined as the change in Rutherford classification at 30 days compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
30 days
Rutherford Classification change, 6 months
大体时间：6 months

Defined as the change in Rutherford classification at 6 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
6 months
Rutherford Classification change, 12 months
大体时间：12 months

Defined as the change in Rutherford classification at 12 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
12 months
Freedom from Major Adverse Events (MAEs)
大体时间：Through 12 months

Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, and perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
Through 12 months
Change in Short Form Health Survey (SF-36) score, 30 days
大体时间：30 days

Defined as the change in SF-36 score at 30 days compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
30 days
Change in Short Form Health Survey (SF-36) score, 6 months
大体时间：6 months

Defined as the change in SF-36 score at 6 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
6 months
Change in Short Form Health Survey (SF-36) score, 12 months
大体时间：12 months

Defined as the change in SF-36 score at 12 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
12 months
Change in Walking Impairment Questionnaire (WIQ) score, 30 days
大体时间：30 days

Defined as the change in WIQ score at 30 days compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
30 days
Change in Walking Impairment Questionnaire (WIQ) score, 6 months
大体时间：6 months

Defined as the change in WIQ score at 6 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
6 months
Change in Walking Impairment Questionnaire (WIQ) score, 12 months
大体时间：12 months

Defined as the change in WIQ score at 12 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
12 months

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

Philips Clinical & Medical Affairs Global

合作者

NAMSA
Syntropic

调查人员

  • 首席研究员：Elizabeth Genovese, MD、University of Pennsylvania
  • 首席研究员：Pradeep Nair, MD、Cardiovascular Institute of the South (CIS)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2024年10月29日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2023年6月7日

首先提交符合 QC 标准的

2023年6月14日

首次发布 (实际的)

2023年6月23日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11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

  • 200201

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

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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