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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

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

155

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • 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
実験的：Thor Treatment

Treatment with the Thor system
デバイス：Thor laser atherectomy

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

他の名前：
  • トールカルシウム修飾

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
Freedom from Major Adverse Events (MAEs)
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Target lesion patency, 30 days
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Philips Clinical & Medical Affairs Global

協力者

NAMSA
Syntropic

捜査官

  • 主任研究者：Elizabeth Genovese, MD、University of Pennsylvania
  • 主任研究者：Pradeep Nair, MD、Cardiovascular Institute of the South (CIS)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年10月29日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2023年6月7日

QC基準を満たした最初の提出物

2023年6月14日

最初の投稿 (実際)

2023年6月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 200201

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

はい

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