RECRUITING

The THOR IDE Study

Conditions

Peripheral Artery Disease Peripheral Artery Stenosis Peripheral Artery Calcification PAD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

The THOR IDE Study

Quick Facts

Study Start:2024-10-29

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05916950

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Life expectancy \>12 months	* Patient has active infection requiring antibiotic therapy * Stenting planned within the target lesion * Known positive for COVID-19 within the last 2 weeks and actively symptomatic * Pregnant (positive pregnancy test) or currently breast feeding * Evidence of Acute Limb Ischemia within 7 days prior to procedure * Cerebrovascular accident (CVA) \<60 days prior to procedure * Myocardial infarction \<60 days prior to procedure * History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening * Known contraindication to aspirin, or antiplatelet/anti-coagulant therapies required for procedure/follow-up * Known allergy to contrast media that cannot adequately be premedicated prior to study procedure * History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS) * Serum creatinine ≥2.5mg/dL (unless dialysis-dependent) tested within a week prior to procedure * Planned lower limb major amputation (above the ankle) * Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with the exception of diagnostic angiography * Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study * The use of specialty balloons, re-entry or additional atherectomy devices is required

Inclusion Criteria

Exclusion 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
* Life expectancy \>12 months

* Patient has active infection requiring antibiotic therapy
* Stenting planned within the target lesion
* Known positive for COVID-19 within the last 2 weeks and actively symptomatic
* Pregnant (positive pregnancy test) or currently breast feeding
* Evidence of Acute Limb Ischemia within 7 days prior to procedure
* Cerebrovascular accident (CVA) \<60 days prior to procedure
* Myocardial infarction \<60 days prior to procedure
* History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening
* Known contraindication to aspirin, or antiplatelet/anti-coagulant therapies required for procedure/follow-up
* Known allergy to contrast media that cannot adequately be premedicated prior to study procedure
* History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS)
* Serum creatinine ≥2.5mg/dL (unless dialysis-dependent) tested within a week prior to procedure
* Planned lower limb major amputation (above the ankle)
* Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with the exception of diagnostic angiography
* Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study
* The use of specialty balloons, re-entry or additional atherectomy devices is required

Contacts and Locations

Study Contact

Jennifer Moore

CONTACT

408-502-3786

jennifer.sample.moore@philips.com

Clarice Scofield

CONTACT

612.803.9461

clarice.scofield@philips.com

Principal Investigator

Ehrin Armstrong, MD

PRINCIPAL_INVESTIGATOR

Interventional Cardiology and Vascular Interventions, Advanced Heart & Vein Center, Denver, CO

Elizabeth Genovese, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Cardiovascular Institute of the South

Houma, Louisiana, 70360

United States

Cardiovascular Institute of the South

Lafayette, Louisiana, 70503

United States

Vascular Breakthroughs

Leominster, Massachusetts, 04153

United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096

United States

Collaborators and Investigators

Sponsor: Philips Clinical & Medical Affairs Global

Ehrin Armstrong, MD, PRINCIPAL_INVESTIGATOR, Interventional Cardiology and Vascular Interventions, Advanced Heart & Vein Center, Denver, CO
Elizabeth Genovese, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-29

Study Completion Date2027-11

Study Record Updates

Study Start Date2024-10-29

Study Completion Date2027-11

Terms related to this study

Additional Relevant MeSH Terms

Peripheral Artery Disease
Peripheral Artery Stenosis
Peripheral Artery Calcification
PAD