Testing the Thor system for treating blocked leg arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the Thor system in treating new calcified lesions in the leg arteries of adults with peripheral artery disease (PAD). Participants will undergo treatment with the Thor system and will be monitored through follow-up visits at various intervals post-procedure. The study will involve up to 30 sites across the U.S., and patients will be screened for eligibility based on specific medical criteria related to their condition. The trial does not include a control group, as all participants will receive the Thor treatment.

Why it matters

Who can join: the full rules

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 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

Exclusion Criteria:

* 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 in the target limb 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 30 days 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 on target limb 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 for treatment of the target lesion.

Angiographic Exclusion Criteria:

* Subject has significant stenosis (\>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
* Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target site at the time of the index procedure.

Where it's running

• Rocky Mountain Regional VA Medical Center
  Aurora, Colorado, United States Recruiting
• Manatee Memorial Hospital
  Bradenton, Florida, United States Recruiting
• Tallahassee Research Institute
  Tallahassee, Florida, United States Recruiting
• Guardian Research Organization
  Winter Park, Florida, United States Recruiting
• Vascular Institute of the Midwest
  Davenport, Iowa, United States Recruiting
• Cardiovascular Institute of the South
  Houma, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Pradeep Nair, MD — Cardiovascular Institute of the South (CIS)
• Study coordinator: Danielle Op den Kamp
• Email: Danielle.op.den.kamp@philips.com
• Phone: +31 (0)6 27218737

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.