NCT07209085

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

SPARC: A Prospective, Multicenter Evaluation of the Safety and Performance of the Artero Intravascular Lithotripsy System for the Treatment of Peripheral Artery Disease and Remodeling Arterial Calcium

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: FastWave Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Peripheral Artery Disease (PAD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-09-01
• Completion: 2027-03-01
• First posted: 2025-10-06
• Last updated: 2025-10-09

Regulatory

• FDA-regulated device study