The THOR IDE Study
Part of paid clinical trials in St. Helena, California.
- Sponsor
- Philips Clinical & Medical Affairs Global
- Study ID
- NCT05916950
- Status
- Recruiting
Conditions
- PAD
- Peripheral Artery Calcification
- Peripheral Artery Disease
- Peripheral Artery Stenosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Thor laser atherectomy — DEVICETreatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system
Study Details
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
Key Dates
- Start date
- Oct 29, 2024
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 155 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Thor TreatmentTreatment with the Thor system
Primary Outcome Measure
Freedom from Major Adverse Events (MAEs) [ Time Frame: 30 Days ]
Central Contacts
- Danielle Op den Kamp+31 (0)6 27218737
- Amanda Franey763-218-9506
Locations (29)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| St. Helena Hospital | St. Helena | California | 94574 | Jennifer Debattista Susan Sherman Leonardo Clavijo, MD (PRINCIPAL_INVESTIGATOR) Michael Gaglia, MD (SUB_INVESTIGATOR) |
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | Jennifer Golden Bilal Aijaz, MD (PRINCIPAL_INVESTIGATOR) Stephen Waldo, MD (SUB_INVESTIGATOR) |
| Manatee Memorial Hospital | Bradenton | Florida | 34205 | Nicolette Weston S. Jay Mathews, MD (PRINCIPAL_INVESTIGATOR) |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | Austin Allen Andres Vargas, MD (PRINCIPAL_INVESTIGATOR) John Katopodis (SUB_INVESTIGATOR) William Dixon (SUB_INVESTIGATOR) |
| Guardian Research Organization | Winter Park | Florida | 32792 | Tiffany King Ashish Gupta, MD (PRINCIPAL_INVESTIGATOR) Sandeep Bajaj (SUB_INVESTIGATOR) |
| Vascular Institute of the Midwest | Davenport | Iowa | 52807 | Amy Olsen Eric Dippel, MD (PRINCIPAL_INVESTIGATOR) |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | Craig Walker, MD (PRINCIPAL_INVESTIGATOR) Pradeep Nair, MD (SUB_INVESTIGATOR) Matthew Finn, MD (SUB_INVESTIGATOR) McCall Walker, MD (SUB_INVESTIGATOR) |
| Cardiovascular Institute of the South | Lafayette | Louisiana | 70503 | Ankur Lodha, MD (PRINCIPAL_INVESTIGATOR) Amit Amin, MD (SUB_INVESTIGATOR) David Tadin, MD (SUB_INVESTIGATOR) |
| The Vascular Care Group | Portland | Maine | 04106 | Nathan Aranson, MD (PRINCIPAL_INVESTIGATOR) Christopher Kwolek, MD (SUB_INVESTIGATOR) Daniel Gorin, MD (SUB_INVESTIGATOR) Todd Lancaster, MD (SUB_INVESTIGATOR) |
| Southcoast Hospitals/Charlton Memorial Hospital | Fall River | Massachusetts | 02720 | Taiwo Esther Kayode Richard Pin, MD (PRINCIPAL_INVESTIGATOR) Mark Perry, MD (SUB_INVESTIGATOR) Brandon Sumpio, MD (SUB_INVESTIGATOR) |
| Vascular Breakthroughs | Leominster | Massachusetts | 04153 | Stephen Hoenig, MD (PRINCIPAL_INVESTIGATOR) Scott James, MD (SUB_INVESTIGATOR) Sebastian DiDato, MD (SUB_INVESTIGATOR) Paul Gagne, MD (SUB_INVESTIGATOR) Edward Arous, MD (SUB_INVESTIGATOR) |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Melanee Schimmel Herbert Aronow, MD (SUB_INVESTIGATOR) Pedro Villablanca, MD (SUB_INVESTIGATOR) Gerald Koenig, MD (SUB_INVESTIGATOR) Vikas Aggarwal, MD (SUB_INVESTIGATOR) Mohammad Alqarqaz, MD (SUB_INVESTIGATOR) Khaldoon Alaswad, MD (SUB_INVESTIGATOR) Kyle Markel, MD (PRINCIPAL_INVESTIGATOR) |
| Henry Ford St John Hospital | Detroit | Michigan | 22201 | Megan Henkel Thomas Davis, Dr (PRINCIPAL_INVESTIGATOR) |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | Andrew McElvarr Richard Kovach, MD (PRINCIPAL_INVESTIGATOR) Gregory Domer, MD (SUB_INVESTIGATOR) |
| Heart and Vascular Institute of Central Jersey | New Brunswick | New Jersey | 08901 | Ramzan Zakir, MD (PRINCIPAL_INVESTIGATOR) |
| Atlantic Medical Imaging of New jersey | Vineland | New Jersey | 08360 | Lenice Valdes Micah Watts, MD (PRINCIPAL_INVESTIGATOR) Nicholas Petruzzi, MD (SUB_INVESTIGATOR) Ramkrishna Patel, MD (SUB_INVESTIGATOR) |
| Mount Sinai Hospital | New York | New York | 10029 | Vanna Nicasio Prakash Krishnan, MD (PRINCIPAL_INVESTIGATOR) David Song, MD (SUB_INVESTIGATOR) Vishal Kapur, MD (SUB_INVESTIGATOR) Raman Sharma (SUB_INVESTIGATOR) |
| New York Presbyterian Hospital/Columbia University Irving Medical Center | New York | New York | 10029 | Claudia Musat Virendra Patel, MD (PRINCIPAL_INVESTIGATOR) Thomas O'Donnell, MD (SUB_INVESTIGATOR) Nicholas Morrissey (SUB_INVESTIGATOR) Danielle Bajakian (SUB_INVESTIGATOR) |
| Vascular Solutions of North Carolina | Cary | North Carolina | 27518 | Sid Rao, Dr. (PRINCIPAL_INVESTIGATOR) |
| Premier Cardiovascular Institute | Fairborn | Ohio | 45324 | Christina Weller Sagger Mawri, MD (PRINCIPAL_INVESTIGATOR) James Pan, MD (SUB_INVESTIGATOR) |
| Ascension St. John | Bartlesville | Oklahoma | 74006 | Mary Harris Anderson Merhle, MD (PRINCIPAL_INVESTIGATOR) Michael Megaly, MD (SUB_INVESTIGATOR) |
| UPMC | Mechanicsburg | Pennsylvania | 17050 | William Bachinsky, Dr (PRINCIPAL_INVESTIGATOR) |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Elizabeth Genovese, MD (PRINCIPAL_INVESTIGATOR) Shang Loh, MD (SUB_INVESTIGATOR) Alexander Fairman, MD (SUB_INVESTIGATOR) Douglas Troutman, MD (SUB_INVESTIGATOR) |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | Antonis Pratsos, MD (PRINCIPAL_INVESTIGATOR) Manju Jayanna, MD (SUB_INVESTIGATOR) Sarang Mangalmurti, MD (SUB_INVESTIGATOR) |
| The Miriam Hospital | Providence | Rhode Island | 02905 | Peter Soukas, MD (PRINCIPAL_INVESTIGATOR) Pieter de Klerk, MD (SUB_INVESTIGATOR) |
| Vascular Institute of Chattanooga | Chattanooga | Tennessee | 37421 | Chris LeSar, MD (PRINCIPAL_INVESTIGATOR) William Harris, DO (SUB_INVESTIGATOR) |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Jarrett Hubbard Michael Siah, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor, Scott & White, The Heart Hospital | Plano | Texas | 75093 | Sameh Sayfo, MD (PRINCIPAL_INVESTIGATOR) Chadi Dib, MD (SUB_INVESTIGATOR) Tony Das, MD (SUB_INVESTIGATOR) |
| Sentara Health Research Center | Norfolk | Virginia | 23507 | Sarah Keith Sarah Havert David Dexter, MD (PRINCIPAL_INVESTIGATOR) Animesh Rathore, MD (SUB_INVESTIGATOR) Priyam Vyas, MD (SUB_INVESTIGATOR) |
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