The THOR IDE Study

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient age is ≥18 years

• Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form

• Patient is able to walk unassisted or with non-motorized assistive devices

• Patient has PAD with documented Rutherford Class 2-4 of the target limb

• Anticipated life expectancy \>12 months, in the opinion of the investigator at the time of enrollment.

⁃ Angiographic Inclusion Criteria:

• Patient has de novo atherosclerotic disease of the native SFA and/or the popliteal arteries

• Target lesion has ≥70% diameter stenosis by investigator via visual assessment

• Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions.

• Chronic total occlusion lesion length is \<100mm of the total ≤150mm target lesion

• Minimum reference vessel diameter (RVD) 4.0mm by visual estimate

• Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations

• At least one patent tibial vessel (defined as \<50% stenosis) with runoff to the foot

• Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria

Locations
United States
California
St. Helena Hospital
RECRUITING
St. Helena
Colorado
Rocky Mountain Regional VA Medical Center
RECRUITING
Aurora
Florida
Manatee Memorial Hospital
RECRUITING
Bradenton
Guardian Research Organization
RECRUITING
Winter Park
Iowa
Vascular Institute of the Midwest
RECRUITING
Davenport
Louisiana
Cardiovascular Institute of the South
RECRUITING
Houma
Cardiovascular Institute of the South
RECRUITING
Lafayette
Massachusetts
Southcoast Hospitals/Charlton Memorial Hospital
RECRUITING
Fall River
Vascular Breakthroughs
RECRUITING
Leominster
Maine
The Vascular Care Group
RECRUITING
Portland
Michigan
Henry Ford Hospital
RECRUITING
Detroit
North Carolina
Vascular Solutions of North Carolina
RECRUITING
Cary
New Jersey
Heart and Vascular Institute of Central Jersey
RECRUITING
New Brunswick
Atlantic Medical Imaging of New jersey
RECRUITING
Vineland
New York
Columbia University Irving Medical Center/New York Presbyterian Hospital
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
Ohio
Premier Cardiovascular Institute
RECRUITING
Fairborn
Oklahoma
Ascension St. John
RECRUITING
Bartlesville
Oregon
Advanced Vascular Centers
RECRUITING
Portland
Pennsylvania
UPMC
RECRUITING
Mechanicsburg
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Lankenau Institute for Medical Research
RECRUITING
Wynnewood
Rhode Island
The Miriam Hospital
RECRUITING
Providence
Tennessee
Vascular Institute of Chattanooga
RECRUITING
Chattanooga
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Baylor, Scott & White, The Heart Hospital
RECRUITING
Plano
Virginia
Sentara Health Research Center
RECRUITING
Norfolk
Contact Information
Primary
Jennifer Moore
jennifer.sample.moore@philips.com
408-502-3786
Backup
Clarice Scofield
clarice.scofield@philips.com
612.803.9461
Time Frame
Start Date: 2024-10-29
Estimated Completion Date: 2027-12
Participants
Target number of participants: 155
Treatments
Experimental: Thor Treatment
Treatment with the Thor system
Sponsors
Collaborators: Syntropic Corelab, NAMSA
Leads: Philips Clinical & Medical Affairs Global

This content was sourced from clinicaltrials.gov