Health Trials

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 group

Locations

29
California
St. Helena Hospital94574, St. Helena United States
Colorado
Rocky Mountain Regional VA Medical Center80045, Aurora United States
Florida
Manatee Memorial Hospital34205, Bradenton United States
Tallahassee Research Institute32308, Tallahassee United States

Sponsors and collaborators

Philips Clinical & Medical Affairs Global

Lead sponsor

NAMSA

Collaborator

Syntropic Corelab

Collaborator

Source ClinicalTrials.gov