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NCT05916950 · ClinicalTrials.gov registry record · NA

The THOR IDE Study

A NA study of Peripheral Artery Disease and PAD, sponsored by Philips Clinical & Medical Affairs Global.

Recruiting
Registry status
NA
Development phase
155
Enrollment target
20
Study locations

NCT05916950 is a NA study of Peripheral Artery Disease and PAD that is actively recruiting participants, run by Philips Clinical & Medical Affairs Global. The registered enrollment target is 155 participants, above the 124-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT05916950, a NA study of Peripheral Artery Disease and PAD, is actively recruiting participants, sponsored by Philips Clinical & Medical Affairs Global.

RECRUITING
Registry status
NA
Development phase
155 participants
Enrollment target
20
Study locations

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

Interventions

  • DEVICE Thor laser atherectomy

Study Locations (20)

Florida

  • Manatee Memorial Hospital - Bradenton
  • Tallahassee Research Institute - Tallahassee
  • Guardian Research Organization - Winter Park

New Jersey

  • Deborah Heart and Lung Center - Browns Mills
  • Heart and Vascular Institute of Central Jersey - New Brunswick
  • Atlantic Medical Imaging of New jersey - Vineland

Louisiana

  • Cardiovascular Institute of the South - Houma
  • Cardiovascular Institute of the South - Lafayette

Massachusetts

  • Southcoast Hospitals/Charlton Memorial Hospital - Fall River
  • Vascular Breakthroughs - Leominster

Michigan

  • Henry Ford St John Hospital - Detroit
  • Henry Ford Hospital - Detroit

New York

  • Mount Sinai Hospital - New York
  • New York Presbyterian Hospital/Columbia University Irving Medical Center - New York

California

  • St. Helena Hospital - St. Helena

Colorado

  • Rocky Mountain Regional VA Medical Center - Aurora

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2024-10-29
Est. Completion 2027-12
Phase NA

What the Registry Record Tells You About NCT05916950

The ClinicalTrials.gov registry entry for NCT05916950 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 124-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (25% higher). The listed sponsor is Philips Clinical & Medical Affairs Global, which has 45 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Peripheral Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Thor laser atherectomy is the first listed.

NCT05916950 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, New Jersey, Louisiana.

Frequently Asked Questions

What is clinical trial NCT05916950 about?

NCT05916950 is a clinical study titled "The THOR IDE Study". 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 t...

What is the current status of trial NCT05916950?

This trial is currently recruiting. It is a NA study. The enrollment target is 155 participants. The study started on 2024-10-29. Estimated completion is 2027-12.

What conditions does trial NCT05916950 study?

This clinical trial studies the following conditions: Peripheral Artery Disease, PAD, Peripheral Artery Stenosis, Peripheral Artery Calcification.

What interventions are being tested in trial NCT05916950?

The interventions under investigation include: Thor laser atherectomy (DEVICE).

Who is sponsoring clinical trial NCT05916950?

This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05916950 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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