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The THOR IDE Study

ConditionsPeripheral Artery DiseasePeripheral Artery StenosisPeripheral Artery CalcificationPAD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilips Clinical & Medical Affairs Global

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Thor laser atherectomy

    Device

    Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system

Treatment groups

155 Participants
are divided into 1 treatment group
Group A: Thor TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Freedom from Major Adverse Events (MAEs)

Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve

Time frame
30 Days
2

Procedural Success

Defined as residual diameter stenosis ≤50% at the end of the procedure as determined by angiographic core lab

Time frame
At completion of the procedure

Secondary outcomes

1

Target lesion patency, 30 days

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram

Time frame
30 days
2

Target lesion patency, 6 months

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram

Time frame
6 months
3

Target lesion patency, 12 months

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram

Time frame
12 months
4

Clinically-driven target lesion revascularization

Defined as repeat revascularization procedure of the target lesion if PSVR is ≥2.5 by DUS or if angiography shows a percent diameter stenosis \>50% and there are worsening clinical symptoms, worsening Rutherford Clinical Category or ABI that is clearly referable to the target lesion.

Time frame
Through 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philips Clinical & Medical Affairs Global

Lead sponsor

NAMSA

Collaborator

Syntropic Corelab

Collaborator

Source ClinicalTrials.gov
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