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

Study acronym: SPARC
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 9, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study title expanded, about 7 wordsv3
  2. Eligibility criteria expanded, about 496 words
    • Secondary endpoints revised (8)
    • Study description shortened, about 132 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07209085
Lead Sponsor FastWave Medical
Collaborators: Rede Optimus Hospitalar SA, Medical Metrics Diagnostics, Inc
Conditions
(from sponsor)		 Peripheral Artery Disease (PAD)
Related terms Peripheral Arterial Disease, Vascular Calcification
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov