A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)
NCT ID: NCT07209085
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2025-12-31
2027-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: FastWave Artero™ IVL System
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Subject is ≥ 18 years of age.
4. Rutherford Clinical Category 2, 3 or 4
5. Resting ABI of ≤0.90, or ≤0.75 after exercise, of the target leg.
6. Lesion calcification is moderate or severe using the PARC3calcium classification definition, or by intravascular ultrasound (IVUS) determined by the investigator.
1. Moderate is defined as ≥ 180º to 270º and \< 50% of the total lesion length.
2. Severe is defined as \>270º and \> than 50% of the total lesion length.
7. Estimated life expectancy \>1 year, in the opinion of the investigator at the time of enrollment.
8. Target lesion that is in a native de novo femoral-popliteal arteries. Non-target lesions can be in the iliac arteries (inflow).
9. The subject is a suitable candidate for angiography and endovascular intervention, in the investigator's opinion or per the hospital guidelines.
10. In the opinion of the investigator by visual estimate, the target lesion is ≥70% stenosis or is occluded.
11. According to the visual estimate, the target lesion reference vessel diameter is between 3.5mm and 8.0mm.
12. The total planned target lesion length must be ≤220 mm.
1. 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.
2. Multiple target vessel beds and discrete (non-contiguous) lesions may be treated, provided the combined total length of all treated lesions does not exceed 220 mm.
13. 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.
14. Retrograde access is permitted for lesion crossing; however, the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System must be deployed from antegrade (either ipsilateral or contralateral) access.
Exclusion Criteria
2. Rutherford Clinical Categories 0, 1, 5, and 6.
3. The investigator determined no or mild calcium in the target lesion.
4. Subject has outflow disease in which no tibial vessel has \<50% stenosis. Staged or concomitant intervention to the tibial vessels is not allowed.
5. 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.
6. 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.
7. Inability to pass the guidewire across the target lesion.
8. In-stent restenosis within the lesion(s) to be treated.
9. Lesions within autologous or synthetic vessel grafts.
10. Evidence of aneurysm or thrombus in the vessels to be treated.
11. 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.
12. Intervention on the contralateral limb is required within the next 14 days.
13. History of thrombolytic therapy within two weeks of enrollment.
14. 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.
15. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
16. Myocardial infarction within 60 days prior to enrollment.
17. History of stroke within 60 days prior to enrollment.
18. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
19. Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 µmol/L, or on dialysis.
20. Subject has an active infection requiring antibiotic therapy.
21. Subject has known allergy to contrast agents, medications, or catheter materials used to perform endovascular intervention that cannot be adequately pre-treated.
22. Subject is pregnant or nursing.
23. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
24. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
18 Years
ALL
No
Sponsors
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Rede Optimus Hospitalar SA
NETWORK
Medical Metrics Diagnostics, Inc
INDUSTRY
FastWave Medical
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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FW100206/ Rev A
Identifier Type: -
Identifier Source: org_study_id
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