RecruitingNot ApplicableNCT05916950

The THOR IDE Study

Sponsor

Philips Clinical & Medical Affairs Global

Enrollment

155 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Peripheral Artery Disease PAD Peripheral Artery Stenosis Peripheral Artery Calcification

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Thor laser atherectomy for people with pad, peripheral artery calcification, and other related conditions. The study is currently recruiting participants at 29 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEThor laser atherectomy

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

Locations(29)

St. Helena Hospital

St. Helena, California, United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Manatee Memorial Hospital

Bradenton, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Guardian Research Organization

Winter Park, Florida, United States

Vascular Institute of the Midwest

Davenport, Iowa, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Cardiovascular Institute of the South

Lafayette, Louisiana, United States

The Vascular Care Group

Portland, Maine, United States

Southcoast Hospitals/Charlton Memorial Hospital

Fall River, Massachusetts, United States

Vascular Breakthroughs

Leominster, Massachusetts, United States

Henry Ford St John Hospital

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Heart and Vascular Institute of Central Jersey

New Brunswick, New Jersey, United States

Atlantic Medical Imaging of New jersey

Vineland, New Jersey, United States

Mount Sinai Hospital

New York, New York, United States

New York Presbyterian Hospital/Columbia University Irving Medical Center

New York, New York, United States

Vascular Solutions of North Carolina

Cary, North Carolina, United States

Premier Cardiovascular Institute

Fairborn, Ohio, United States

Ascension St. John

Bartlesville, Oklahoma, United States

UPMC

Mechanicsburg, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

Vascular Institute of Chattanooga

Chattanooga, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor, Scott & White, The Heart Hospital

Plano, Texas, United States

Sentara Health Research Center

Norfolk, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05916950

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