An interventional study of FastWave Artero™ Peripheral IVL System in Peripheral Artery Disease (PAD), sponsored by FastWave Medical. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by FastWave Medical · Not applicable, Interventional, and Treatment
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.
Peripheral artery disease (PAD) happens when plaque and calcium build up inside the arteries of the legs. This buildup narrows the arteries and limits blood flow, which can cause pain, limited mobility, and slow healing of wounds. Treating arteries that contain a large amount of calcium can be difficult because the calcium makes the artery wall stiff and hard to open with standard balloons or stents.
The FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is designed to improve treatment for people with moderate to severe calcium in their leg arteries. The system includes a generator and a small balloon catheter that emits short bursts of sound energy (lithotripsy). These sound waves gently fracture calcium deposits while protecting the softer tissue of the artery. After the calcium is cracked, the artery can be widened using low balloon pressure, which may help blood flow more easily and lower the risk of tearing or other damage.
This prospective, multi-center, single-arm clinical study will evaluate the safety and effectiveness of the FastWave Artero™ IVL System in adults with PAD who have calcified blockages in the femoral or popliteal arteries. The study will enroll up to 110 participants at as many as 30 U.S. investigational sites. All participants will receive the FastWave IVL treatment during a standard minimally invasive endovascular procedure.
The primary safety endpoint is the proportion of participants free from major adverse events (such as serious vessel injury, emergency surgery, or unplanned major amputation) through 30 days after the procedure.
The primary effectiveness endpoint is successful treatment of the blocked artery, defined as less than 50 percent narrowing remaining after IVL, with or without the use of additional devices.
Secondary assessments will include degree of residual narrowing (≤30%), use of adjunctive therapies, and improvements in vessel patency and clinical symptoms through 6 months. These data will also be used to compare outcomes to a historical performance goal based on prior intravascular lithotripsy studies in peripheral arteries.
Participants will be followed at discharge, 30 days, and 6 months to assess safety, vessel imaging, and symptom changes. A small number of sites will also participate in an optional intravascular ultrasound (IVUS) sub-study to collect detailed imaging data on how the FastWave device interacts with the artery wall.
Findings from this pivotal study are intended to support a future U.S. Food and Drug Administration (FDA) 510(k) submission for the FastWave Artero™ Peripheral IVL System as a treatment for calcified peripheral arterial disease.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 110 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →This is the only study on the registry with FastWave Medical as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Lesion calcification is moderate or severe using the PARC3calcium classification definition, or by intravascular ultrasound (IVUS) determined by the investigator.
The total planned target lesion length must be ≤220 mm.
Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50% distal to the target lesion.
a. If the peroneal artery, at least one collateral must supply the foot.
Exclusion Criteria
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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).
Time frame: 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.
Time frame: 30 Days Post-Procedure
Residual Stenosis ≤30%
The percentage of subjects achieving ≤30% residual stenosis in the target lesion as measured by angiography following treatment.
Time frame: Immediately post-procedure
Incidence of Adjunctive Therapy
The percentage of subjects requiring adjunctive therapy (angioplasty, stent placement, or other devices) to achieve procedural success.
Time frame: Immediately post-procedure
Primary Patency
The percentage of target lesions maintaining primary patency, defined as freedom from clinically driven target lesion revascularization and duplex ultrasound evidence of ≤50% restenosis.
Time frame: 30 days and 6 months post-procedure
Freedom from Major Adverse Events (MAE) at 6 Months
The percentage of subjects free from MAE through 6 months following the index procedure, using the same MAE definition as the primary safety endpoint.
Time frame: 6 months post-procedure
Change in Ankle-Brachial Index (ABI) from Baseline
The Ankle-Brachial Index (ABI) is the ratio of ankle to arm systolic blood pressure. Scale range: 0.00-1.30 (values \>1.30 indicate non-compressible arteries). Directionality: Higher ABI within the normal range indicates a better outcome (better limb perfusion); lower ABI indicates worse perfusion. If ABI is non-compressible (\>1.30), Toe-Brachial Index (TBI) will be used per protocol.
Time frame: Baseline to 30 days and 6 months
Change in Rutherford Clinical Category (RCC)
Change in symptom severity using Rutherford Clinical Categories compared with baseline.
Time frame: Baseline to 30 days and 6 months
Change in Quality of Life (EQ-5D-5L) from Baseline
The EQ-5D-5L Index summarizes health across 5 domains with country-specific weights. Scale range (U.S. value set): -0.573 to 1.000. Directionality: Higher scores indicate a better outcome (better health status).
Time frame: Baseline to 30 days and 6 months
Change in Walking Impairment Questionnaire (WIQ) Scores from Baseline
The Walking Impairment Questionnaire (WIQ) assesses walking function across subscales (Distance, Speed, Stair-Climbing). Scale range (each subscale): 0 to 100. Directionality: Higher scores indicate a better outcome (less walking limitation/better function). Report each subscale separately.
Time frame: Baseline to 30 days and 6 months
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared. Study results will be posted on ClinicalTrials.gov as required.
No publications or documents are linked to this record.
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