The THOR IDE Study

Recruiting now · Not applicable

Conditions studied: Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PAD

In brief

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

Key facts

Study ID

NCT05916950

Run by

Philips Clinical & Medical Affairs Global

People needed

155

Starts

2024-10-29

Expected to finish

2027-12-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• St. Helena Hospital — St. Helena, California, United States (enrolling)
• Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States (enrolling)
• Manatee Memorial Hospital — Bradenton, Florida, United States (enrolling)
• Tallahassee Research Institute — Tallahassee, Florida, United States (enrolling)
• Guardian Research Organization — Winter Park, Florida, United States (enrolling)
• Vascular Institute of the Midwest — Davenport, Iowa, United States (enrolling)
• Cardiovascular Institute of the South — Houma, Louisiana, United States (enrolling)
• Cardiovascular Institute of the South — Lafayette, Louisiana, United States (enrolling)
• The Vascular Care Group — Portland, Maine, United States (enrolling)
• Southcoast Hospitals/Charlton Memorial Hospital — Fall River, Massachusetts, United States (enrolling)
• Vascular Breakthroughs — Leominster, Massachusetts, United States (enrolling)
• Henry Ford St John Hospital — Detroit, Michigan, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States (enrolling)
• Heart and Vascular Institute of Central Jersey — New Brunswick, New Jersey, United States (enrolling)
• Atlantic Medical Imaging of New jersey — Vineland, New Jersey, United States (enrolling)
• Mount Sinai Hospital — New York, New York, United States (enrolling)
• New York Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Vascular Solutions of North Carolina — Cary, North Carolina, United States (enrolling)
• Premier Cardiovascular Institute — Fairborn, Ohio, United States (enrolling)
• Ascension St. John — Bartlesville, Oklahoma, United States (enrolling)
• UPMC — Mechanicsburg, Pennsylvania, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States (enrolling)
• The Miriam Hospital — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.