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Recruiting
NCT05916950
The THOR IDE Study
Conditions: Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PAD
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 155
Sponsor: Philips Clinical & Medical Affairs Global
Location: St. Helena Hospital St. Helena California
Summary
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
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT05916950). StuddyBuddy aggregates publicly available trial information.