A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)

NCT07209085 | Not Yet Recruiting FDA Device

• 1 other identifier: FW100206/ Rev A
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled blockages in their leg arteries. The study will test the idea that using sound waves inside the artery can safely break up calcium and make it easier to open the artery so blood can flow better. The main question this study is trying to answer is: Can treatment with the FastWave Artero™ IVL System safely widen blocked leg arteries and lower the chance of serious problems during or after the procedure? About 110 adults at up to 30 medical centers in the United States will take part. Everyone in the study will receive the IVL treatment. During the study, participants will: Have a minimally invasive procedure using the FastWave IVL System Stay for a short observation period after the procedure Return for follow-up visits about 30 days and 6 months later Researchers will look at how well the arteries open, how long they stay open, and whether any major complications occur. The results will help determine if the FastWave Artero™ IVL System can be used as a safe and effective treatment for people with PAD and severe calcium buildup in the leg arteries.

Conditions

Peripheral Artery Disease (PAD)

Keywords

Peripheral Artery Disease (PAD); Lower Extremity Arterial Disease; Femoropopliteal Artery; Arterial Calcification; Vascular Calcification; Endovascular Therapy; Intravascular Lithotripsy (IVL); FastWave Artero IVL System; Angioplasty

Outcome Measures

Primary Outcomes (2)

• Procedural Success

  Procedural success is defined as ≤50% residual stenosis in the target lesion after treatment with the FastWave Artero™ IVL System, with or without adjunctive therapy (e.g., angioplasty or stenting).

  Immediately Following the Index Procedure

• Freedom from Major Adverse Events (MAE) at 30 Days

  The percentage of subjects free from major adverse events (MAE) through 30 days following the index procedure. MAE is defined as unplanned surgical revascularization of the target limb, major amputation of the target limb, symptomatic thrombosis or embolism requiring intervention, vessel perforation requiring covered stent, or unresolved flow-limiting dissection.

  30 Days Post-Procedure

Secondary Outcomes (8)

• Residual Stenosis ≤30%

  Immediately post-procedure

• Incidence of Adjunctive Therapy

  Immediately post-procedure

• Primary Patency

  30 days and 6 months post-procedure

• Freedom from Major Adverse Events (MAE) at 6 Months

  6 months post-procedure

• Change in Ankle-Brachial Index (ABI) from Baseline

  Baseline to 30 days and 6 months

Study Arms (1)

Experimental: FastWave Artero™ IVL System

EXPERIMENTAL

All participants in this single-arm study will receive treatment with the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System during a single endovascular index procedure performed to open blocked femoropopliteal arteries that contain moderate to severe calcium buildup. The IVL System includes a generator and a balloon-based catheter that delivers short bursts of pulsatile sonic pressure waves inside the artery to fracture calcium within the vessel wall. This improves vessel flexibility and allows dilation at low balloon pressures to restore blood flow. During the index procedure, investigators may perform multiple balloon inflations or treatment cycles as needed to treat the full length of the target lesion. Adjunctive therapies, such as balloon angioplasty or stent placement, may be used at the investigator's discretion to achieve optimal vessel opening.

Device: FastWave Artero™ Peripheral IVL System

Interventions

FastWave Artero™ Peripheral IVL System DEVICE

The FastWave Artero™ Peripheral IVL System includes a generator and a balloon-based catheter designed to treat calcified blockages in peripheral arteries. During a single endovascular index procedure, the catheter is positioned within the target femoropopliteal artery and inflated at low pressure. The device emits short bursts of pulsatile sonic pressure waves that fracture calcium deposits, improving vessel flexibility and allowing dilation at low balloon pressures to restore blood flow. Multiple inflations may be performed as needed. Adjunctive angioplasty or stenting may be used at the investigator's discretion.

Also known as: FastWave Artero IVL Catheter, Intravascular Lithotripsy System

Experimental: FastWave Artero™ IVL System

Eligibility Criteria

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

You may qualify if:

• Subject is able and willing to comply with all assessments in the study.
• Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
• Subject is ≥ 18 years of age.
• Rutherford Clinical Category 2, 3 or 4
• Resting ABI of ≤0.90, or ≤0.75 after exercise, of the target leg.
• Lesion calcification is moderate or severe using the PARC3calcium classification definition, or by intravascular ultrasound (IVUS) determined by the investigator.
• Moderate is defined as ≥ 180º to 270º and \< 50% of the total lesion length.
• Severe is defined as \>270º and \> than 50% of the total lesion length.
• Estimated life expectancy \>1 year, in the opinion of the investigator at the time of enrollment.
• Target lesion that is in a native de novo femoral-popliteal arteries. Non-target lesions can be in the iliac arteries (inflow).
• The subject is a suitable candidate for angiography and endovascular intervention, in the investigator's opinion or per the hospital guidelines.
• In the opinion of the investigator by visual estimate, the target lesion is ≥70% stenosis or is occluded.
• According to the visual estimate, the target lesion reference vessel diameter is between 3.5mm and 8.0mm.
• The total planned target lesion length must be ≤220 mm.
• Tandem lesions (i.e., two or more lesions in close proximity) may be considered a single lesion if the distance between them is ≤ 30 mm.

You may not qualify if:

• Planned use of atherectomy, scoring or cutting balloons, or any investigational device other than lithotripsy.
• Rutherford Clinical Categories 0, 1, 5, and 6.
• The investigator determined no or mild calcium in the target lesion.
• Subject has outflow disease in which no tibial vessel has \<50% stenosis. Staged or concomitant intervention to the tibial vessels is not allowed.
• The subject has significant inflow disease, defined as \>50% stenosis or occlusion in the inflow tract proximal to the target lesion, that has not been successfully treated prior to treatment of the superficial femoral artery (SFA) or popliteal lesion.
• a. Successful treatment is defined as residual stenosis ≤30% without a flow-limiting dissection or vessel perforation.
• The subject has significant outflow disease in which no tibial vessel has \<50% stenosis. Staged or concomitant intervention to the tibial vessel is not allowed.
• Inability to pass the guidewire across the target lesion.
• In-stent restenosis within the lesion(s) to be treated.
• Lesions within autologous or synthetic vessel grafts.
• Evidence of aneurysm or thrombus in the vessels to be treated.
• History of prior endovascular or surgical intervention on the index limb within 14 days prior to the index procedure, unless part of a pre-specified, staged treatment plan.
• Intervention on the contralateral limb is required within the next 14 days.
• History of thrombolytic therapy within two weeks of enrollment.
• Subject has a known hypercoagulable state, coagulopathy, or has a bleeding diathesis, thrombocytopenia with platelet counts less than 100,000/microliter, or International Normalized Ratio (INR) \>1.5.

Sponsors & Collaborators

• FastWave Medical: lead
• Rede Optimus Hospitalar SA: collaborator
• Medical Metrics Diagnostics, Inc: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease; Vascular Calcification

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Sherry Roberts

CONTACT

(502) 262-9307; sherry@fastwavemedical.com

Jillian Clark

CONTACT

(806) 577-8390; jillian@fastwavemedical.com

Study Design

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

Model Details: Single-arm pivotal study evaluating the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in subjects with femoropopliteal arterial disease and moderate to severe calcification.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 6, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share