RecruitingPeripheral Artery DiseasePeripheral Artery StenosisPeripheral Artery Calcification

The THOR IDE Study

Eligible age

18+ yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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

Sponsor: Philips Clinical & Medical Affairs Global

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

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