Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
155 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-10-29
Study Completion Date
2027-12-31
Brief Summary
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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
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
Detailed Description
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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.
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.
Conditions
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Peripheral Artery Disease
Peripheral Artery Stenosis
Peripheral Artery Calcification
PAD
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Prospective, single-arm, multicenter, and open-label study
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Thor Treatment
Treatment with the Thor system
Group Type
EXPERIMENTAL
Thor laser atherectomy
Intervention Type
DEVICE
Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system
Interventions
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Thor laser atherectomy
Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system
Intervention Type
DEVICE
Other Intervention Names
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Thor calcium modification
Eligibility Criteria
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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.
* 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
* 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.
* 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.
* 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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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NAMSA
OTHER
Sponsor Role
collaborator
Syntropic Corelab
UNKNOWN
Sponsor Role
collaborator
Philips Clinical & Medical Affairs Global
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Pradeep Nair, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Institute of the South (CIS)
Elizabeth Genovese, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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St. Helena Hospital
St. Helena, California, United States
Site Status
RECRUITING
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
Site Status
RECRUITING
Manatee Memorial Hospital
Bradenton, Florida, United States
Site Status
RECRUITING
Guardian Research Organization
Winter Park, Florida, United States
Site Status
RECRUITING
Vascular Institute of the Midwest
Davenport, Iowa, United States
Site Status
RECRUITING
Cardiovascular Institute of the South
Houma, Louisiana, United States
Site Status
RECRUITING
Cardiovascular Institute of the South
Lafayette, Louisiana, United States
Site Status
RECRUITING
The Vascular Care Group
Portland, Maine, United States
Site Status
RECRUITING
Southcoast Hospitals/Charlton Memorial Hospital
Fall River, Massachusetts, United States
Site Status
RECRUITING
Vascular Breakthroughs
Leominster, Massachusetts, United States
Site Status
RECRUITING
Henry Ford Hospital
Detroit, Michigan, United States
Site Status
RECRUITING
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Site Status
RECRUITING
Heart and Vascular Institute of Central Jersey
New Brunswick, New Jersey, United States
Site Status
RECRUITING
Atlantic Medical Imaging of New jersey
Vineland, New Jersey, United States
Site Status
RECRUITING
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States
Site Status
RECRUITING
Mount Sinai Hospital
New York, New York, United States
Site Status
RECRUITING
Vascular Solutions of North Carolina
Cary, North Carolina, United States
Site Status
RECRUITING
Premier Cardiovascular Institute
Fairborn, Ohio, United States
Site Status
RECRUITING
Ascension St. John
Bartlesville, Oklahoma, United States
Site Status
RECRUITING
UPMC
Mechanicsburg, Pennsylvania, United States
Site Status
RECRUITING
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
Site Status
RECRUITING
The Miriam Hospital
Providence, Rhode Island, United States
Site Status
RECRUITING
Vascular Institute of Chattanooga
Chattanooga, Tennessee, United States
Site Status
RECRUITING
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Site Status
RECRUITING
Baylor, Scott & White, The Heart Hospital
Plano, Texas, United States
Site Status
RECRUITING
Sentara Health Research Center
Norfolk, Virginia, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, Micari A, Lee A, Metzger C, Palena LM, Rundback J; EX-PAD-03 Investigators. Acute and 30-Day Safety and Effectiveness Evaluation of Eximo Medical's B-Laser, a Novel Atherectomy Device, in Subjects Affected With Infrainguinal Peripheral Arterial Disease: Results of the EX-PAD-03 Trial. Cardiovasc Revasc Med. 2020 Jan;21(1):86-92. doi: 10.1016/j.carrev.2018.11.022. Epub 2018 Nov 29.
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Roberts D, Niazi K, Miller W, Krishnan P, Gammon R, Schreiber T, Shammas NW, Clair D; DEFINITIVE Ca(+)(+) Investigators. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca(+)(+) trial. Catheter Cardiovasc Interv. 2014 Aug 1;84(2):236-44. doi: 10.1002/ccd.25384. Epub 2014 Feb 5.
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Shammas NW, Shammas GA, Jones-Miller S, Shammas WJ, Bou-Dargham B, Shammas AN, Banerjee S, Rachwan RJ, Daher GE. Long-term outcomes with Jetstream atherectomy with or without drug coated balloons in treating femoropopliteal arteries: A single center experience (JET-SCE). Cardiovasc Revasc Med. 2018 Oct;19(7 Pt A):771-777. doi: 10.1016/j.carrev.2018.02.003. Epub 2018 Feb 9.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
200201
Identifier Type: -
Identifier Source: org_study_id