Clinical Trial

The THOR IDE Study

Study acronym: THOR

Recruiting

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

Protocol Amendment History 22 amendments

This ClinicalTrials.gov record has been amended 22 times since 2023-06-14; most recent amendment 2026-06-10.

Status change: Not Yet Recruiting → Recruiting 2024-11-08

Trial Details

NCT Number	NCT05916950
Lead Sponsor	Philips Clinical & Medical Affairs Global Collaborators: NAMSA, Syntropic Corelab
Conditions	Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PAD
Enrollment	155 participants
Start Date	2024-10-29
Primary Completion	2026-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-11