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ACTIVE NOT RECRUITING NA

Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

NCT05007925 · View on ClinicalTrials.gov ↗

Study Summary

To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study.

Conditions Studied

Interventions

  • DEVICE Intravascular Lithotripsy

Study Locations (20)

California

  • UCSF Fresno — Fresno
  • Scripps Memorial Hospital — La Jolla
  • Cedars-Sinai Medical Center — Los Angeles
  • Stanford Hospital — Palo Alto
  • UC Davis Health — Sacramento
  • St. Helena Hospital — St. Helena

Massachusetts

  • Massachusetts General Hospital — Boston
  • Southcoast Hospitals Group — New Bedford

Michigan

  • McLaren Bay Heart and Vascular — Bay City
  • McLaren Greater Lansing — Lansing

Missouri

  • St. Luke's Hospital — Kansas City
  • Barnes-Jewish Hospital — St Louis

District of Columbia

  • MedStar Washington Hospital Center — Washington D.C.

Florida

  • Tallahassee Memorial Hospital — Tallahassee

Georgia

  • Piedmont Heart Institute — Atlanta

Illinois

  • Rush University Medical Center — Chicago

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2021-11-18
Est. Completion 2026-04-01
Phase NA

Sponsor

Shockwave Medical

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05007925

The ClinicalTrials.gov registry entry for NCT05007925 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shockwave Medical, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Peripheral Artery Disease appearing as the primary indexed condition, and to 1 intervention — of which Intravascular Lithotripsy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05007925 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05007925 about?

NCT05007925 is a clinical study titled "Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System". To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study.

What is the current status of trial NCT05007925?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2021-11-18. Estimated completion is 2026-04-01.

What conditions does trial NCT05007925 study?

This clinical trial studies the following conditions: Peripheral Artery Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05007925?

The interventions under investigation include: Intravascular Lithotripsy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05007925?

This trial is sponsored by Shockwave Medical, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05007925 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial