IV-X Medical First-in-Human Peripheral Intravascular Lithotripsy Study for PAD

IV-X Medical is conducting a prospective, single-arm, single-center clinical premarket study to evaluate the safety and effectiveness of the IV-X Medical IVL System to treat moderately to severely calcified peripheral arteries in the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries. Up to 25 subjects will be enrolled.

Eligibility criteria are differentiated, where appropriate, by lesion location of above-the-knee (ATK) or below-the-knee (BTK).

Standard Inclusion Criteria:

• Age of subject is >18.
• Rutherford Clinical Category:

• ATK: 2, 3, or 4
• BTK: 4 or 5 (Category 5 will only include patients with ulcers not extending proximal to the metatarsal head)
• Estimated life expectancy >1 year in the opinion of the investigator at the time of enrollment.
• Subject or subject's legal representative agrees to participate and comply with the study assessments.

Angiographic Inclusion Criteria:

• Subject is a suitable candidate for angiography and endovascular intervention, in the opinion of the investigator or per hospital guideline.
• De novo target lesion that is located in a native vessel as follows:

• ATK: Iliac, superficial femoral artery (SFA), popliteal artery (extends to 2cm above the bifurcation or trifurcation of the tibial artery)
• BTK: distal segment (P3) of the popliteal artery to the ankle joint
• Target lesion reference vessel diameter is between the following sizes by visual estimate:

• ATK: 3.5mm and 12.0mm
• BTK: 2.0mm and 5.0mm
• Target lesion stenosis ≥70% via visual estimate.
• Subject has at least:

• ATK: One (1) patent contiguous vessel with runoff to the foot (not supported by collateral circulation) in the target leg. Vessel patency is defined as no stenosis >50%.
• BTK: Distal constitution of one (1) pedal vessel (< 50% stenosis) (desert foot excluded).
• Ability to pass the guidewire intraluminally by Investigator evaluation across the atherosclerotic lesion, without the use of re-entry devices.
• Calcification is at least moderate with visual evidence of calcification and at least one: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.
• Successful treatment without complications (≤ 30% residual stenosis) of significant stenosis or occlusion of inflow tract proximal to the target treatment zone using percutaneous angioplasty or stent, if applicable (no IVL).

Standard Exclusion Criteria:

• Rutherford Clinical Category 0, 1, or 5 with ulcers extending proximal to the metatarsal head, Category 6, or physically unable to ambulate (e.g., bedridden).
• Subject has active infection requiring IV antibiotics in the target leg.
• Planned major amputation of the target leg (above the ankle joint or higher).
• Prior endovascular or surgical procedure on the index limb within the 30 days prior to enrollment (including thrombolysis).
• Subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet count less than 100,000/microliter, or international normalized ratio >1.5 at the time of enrollment.
• Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
• Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Myocardial infarction within 60 days prior to enrollment.
• Stroke within 60 days prior to enrollment.
• History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
• Subject has acute or chronic renal disease (serum creatinine of >2.5 mg/dL or eGFR <30) or is on dialysis at the time of enrollment.
• Presence of venous insufficiency with history of venous ulceration in the target limb in the past year.
• Subject is pregnant or nursing.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment.

Angiographic Exclusion Criteria:

• Any stent within the target lesion
• Target lesion(s) within native or synthetic vessel grafts.
• Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
• Use of: (1) CTO re-entry or (2) other non-study IVL devices on the target lesion.
• Lesions within 10mm of the ostium of the SFA
• Evidence of aneurysm or acute thrombus in target vessel.