RecruitingNot ApplicableNCT05916950
The THOR IDE Study
Sponsor
Philips Clinical & Medical Affairs Global
Enrollment
155 participants
Start Date
Oct 29, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria13
- 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.
- 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 Criteria18
- 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.
- 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.
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Interventions
DEVICEThor laser atherectomy
Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT05916950
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