The THOR IDE Study
Philips Clinical & Medical Affairs Global
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
Description
Up to 30 sites in the U.S. will be selected to do this study. Patients with pain in their legs when walking and/or resting that is due to lack of blood flow to their legs may be able to join the study. To join the study patients must also have blockages in their leg arteries that meet the study criteria. Before the Thor procedure, patients will have a screening visit that includes a review of their medical records, questions about their medical history and medications taken for blood thinning or circulation, a physical examination of their legs, a test to check the blood flow in their legs (…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 investiga…
Interventions
- DeviceThor laser atherectomy
Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system
Locations (29)
- St. Helena HospitalSt. Helena, California
- Rocky Mountain Regional VA Medical CenterAurora, Colorado
- Manatee Memorial HospitalBradenton, Florida
- Tallahassee Research InstituteTallahassee, Florida
- Guardian Research OrganizationWinter Park, Florida
- Vascular Institute of the MidwestDavenport, Iowa