A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular… (NCT07209085) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Evaluate the Safety and Effectiveness of the FastWave Arteroâ„¢ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)
110 participantsStarted 2025-12
Plain-language summary
The purpose of this clinical study is to learn if the FastWave Arteroâ„¢ 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 Arteroâ„¢ 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 Arteroâ„¢ IVL System can be used as a safe and effective treatment for people with PAD and severe calcium buildup in the leg arteries.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Planned use of atherectomy, scoring or cutting balloons, or any investigational device other than lithotripsy.
What they're measuring
1
Procedural Success
Timeframe: Immediately Following the Index Procedure
2
Freedom from Major Adverse Events (MAE) at 30 Days
✕. 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.
✕. 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.