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

NCT07747883 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: TP1151
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and performance of the IV-X Medical Intravascular Lithotripsy (IVL) System in adults in order to demonstrate the ability of the IV-X Medical IVL System to safely and effectively deliver IVL treatment calcified peripheral arteries (iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries).

Conditions

Peripheral Artery Disease

Keywords

PAD; IVL; Intravascular Lithotripsy

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint defined as proportion of subjects with one or more new onset Major Adverse Events (MAEs) through 30 days post-procedure.

  Major Adverse Events (MAEs) are defined as: * Clinically driven target limb revascularization * Unplanned amputation of the target limb above the ankle * Device- or procedure-related post-operative death

  30 Days

• Primary Effectiveness Endpoint defined as the number of subjects with post-procedure residual diameter stenosis of <50% (after adjunctive therapy, if used), as assessed by quantitative angiography.

  Day of procedure

Secondary Outcomes (8)

• Secondary Endpoint of Acute Procedural Success with Freedom from Procedural Major Adverse Events.

  Day of Procedure

• Secondary Endpoint of Acute Procedural Success defined as number of procedures with successful IVL treatment delivery in desired location using 2 or fewer catheters.

  Day of Procedure

• Secondary Safety Endpoint defined as the proportion of subjects with one or more device- or procedure-related adverse events (AEs) or serious adverse events (SAEs) through 30 days post-procedure.

  30 Days

• Secondary Safety Endpoint defined as freedom from clinically driven target lesion revascularization (TLR-lesion) at 30 days.

  30 Days

• Change in Rutherford Clinical Category score at 30 days, compared to Baseline.

  30 Days

Study Arms (1)

IVL Treatment Arm

EXPERIMENTAL

Device: IV-X Medical IVL System

Interventions

IV-X Medical IVL System DEVICE

The IV-X Medical Intravascular Lithotripsy (IVL) System (IV-X IVL System) is a balloon-based lithotripsy device designed to treat calcified peripheral artery lesions. The device employs sonic pressure waves to fracture the calcifications, restoring blood flow and improving vascular health.

IVL Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• IVX Medical: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share