이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

THOR IDE 연구 (THOR)

2026년 11월 2일 업데이트: 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

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

155

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Thor Treatment

Treatment with the Thor system
장치: Thor laser atherectomy

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

다른 이름들:
  • 토르 칼슘 수정

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Freedom from Major Adverse Events (MAEs)
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Target lesion patency, 30 days
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Philips Clinical & Medical Affairs Global

협력자

NAMSA
Syntropic

수사관

  • 수석 연구원: Elizabeth Genovese, MD, University of Pennsylvania
  • 수석 연구원: Pradeep Nair, MD, Cardiovascular Institute of the South (CIS)

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 10월 29일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2023년 6월 7일

QC 기준을 충족하는 최초 제출

2023년 6월 14일

처음 게시됨 (실제)

2023년 6월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 200201

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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