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The THOR IDE Study

NCT05916950 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-03-20

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Thor laser atherectomy

Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Syntropic Corelab

    collaborator UNKNOWN

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Principal Investigators

  • Pradeep Nair, MD · Cardiovascular Institute of the South (CIS)

  • Elizabeth Genovese, MD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05916950 on ClinicalTrials.gov