The THOR IDE Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilips Clinical & Medical Affairs Global
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Thor laser atherectomy
Treatment groups
155 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov