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New device aims to restore leg blood flow without Long-Term drugs

NCT ID NCT06321575

Disease control Sponsor: Nipro Vascular Innovations Americas, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests a new tool called Golazo that removes plaque from leg arteries in people with peripheral artery disease (PAD). About 159 adults with moderate to severe symptoms will be treated at up to 20 U.S. sites. The goal is to see if the device is safe and works well to improve blood flow without causing serious problems like re-blockage or amputation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 159 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General inclusion criteria: 1. Age ≥18 years 2. Candidate for atherectomy of the peripheral vasculature in the lower limbs 3. Life expectancy \>1 year in the opinion of the investigator 4. Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise. Subjects with non-compressible arteries shall have a toe brachial index (TBI) assessment. 5. Target limb Rutherford clinical classification category 3 to 5 6. Suitable candidate for angiography and endovascular intervention in the opinion of the investigator 7. Willing and able to comply with the protocol-specified procedures and assessments 8. Informed consent granted Angiographic inclusion criteria: 9. Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation 10. Total treated lesion length ≤20 cm by angiographic visual estimation 11. Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation 12. Target limb will have a minimum of one patent (less than 50% stenosis) below the knee (BTK) vessel crossing the ankle, distal to any target lesion, providing perfusion to the foot at baseline General exclusion criteria: 1. Active infection in the target limb 2. History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days 3. Planned surgical or interventional procedure within 30 days after the index procedure 4. Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days 5. Critical limb ischemia (CLI) with Rutherford clinical classification category 6 6. Significant acute or chronic kidney disease with a GFR \<30 and/or requiring dialysis 7. Acute myocardial infarction (non-ST-elevation myocardial infarction or ST-segment elevation myocardial infarction) or other uncontrolled comorbidity in the opinion of the investigator 8. Myocardial infarction (MI) or stroke within two months of baseline evaluation 9. Pregnant or lactating 10. Subject is participating in another clinical investigation of a device, drug, or procedure that has not completed the study treatment or that clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints) 11. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy 12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count \<125,000/microliter, known coagulopathy, or international normalized ratio (INR) \>1.5 13. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately medicated 14. History of heparin-induced thrombocytopenia (HIT) 15. Any thrombolytic therapy within two weeks of enrollment 16. Target lesion(s) within a native vessel graft or synthetic graft 17. Significant stenosis or occlusion of inflow not successfully treated before the index procedure 18. Any evidence or history of intracranial or gastrointestinal bleeding or intracranial aneurysm 19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 20. One or more of the following complications of the foot: 1. Osteomyelitis that extends to the metatarsal bones. 2. Gangrene involving the plantar skin of the forefoot, midfoot or heel 3. Deep ulcer or large shallow ulcer (\>3cm) involving the plantar skin of the forefoot, midfoot, or heel 4. Any heel ulcer with/without calcaneal involvement 5. Any wound with calcaneal bone involvement 6. Wounds that are deemed to be neuropathic or non-ischemic in nature 7. Wounds that require flap coverage or complete wound management for large soft tissue defect 21. Congestive heart failure with a NYHA functional classification of III or higher Angiographic exclusion criteria: 22. More than 2 lesions to be treated with the investigational device; lesions located within 3 mm may be considered a single tandem lesion 23. Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of the investigational device 24. In-stent restenosis within the target lesion(s) 25. Potentially unstable or flow-limiting dissection, type C or greater 26. Clinical/angiographic evidence of distal embolization 27. Inability to cross the proximal lesion vessel lumen with a guidewire (not subintimal)

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Heart and Vascular Institute

    RECRUITING

    Flemington, New Jersey, 08822, United States

  • Amavita Research Services

    RECRUITING

    Miami, Florida, 33137, United States

    Contact Email: •••••@•••••

  • Baton Rouge General Hospital

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Bellin Health

    RECRUITING

    Green Bay, Wisconsin, 54301, United States

  • Cardiovascular Consultants of South Georgia

    COMPLETED

    Thomasville, Georgia, 31792, United States

  • Cardiovascular Institute of the South - Houma

    RECRUITING

    Houma, Louisiana, 70360, United States

  • Cardiovascular Institute of the South - Lafayette

    RECRUITING

    Lafayette, Louisiana, 70506, United States

  • First Coast Cardiovascular Institute

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • HonorHealth Scottsdale Osborn Medical Center

    WITHDRAWN

    Scottsdale, Arizona, 85251, United States

  • Hope Vascular & Podiatry

    RECRUITING

    Houston, Texas, 77054, United States

  • Merced Vascular

    RECRUITING

    Merced, California, 95340, United States

  • Nextstage Clinical Research - Beaumont

    RECRUITING

    Beaumont, Texas, 77702, United States

  • Nextstage Clinical Research - Waco

    RECRUITING

    Waco, Texas, 76712, United States

  • Pacific Vascular Institute

    RECRUITING

    ‘Aiea, Hawaii, 96701, United States

  • Palm Vascular Center

    RECRUITING

    Fort Lauderdale, Florida, 33312, United States

  • Pulse Cardiovascular Institute

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • Radiology and Imaging Specialists of Lakeland

    COMPLETED

    Lakeland, Florida, 33801, United States

  • Spartanburg Regional Medical Center

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Tennessee Center for Clinical Trials

    RECRUITING

    Tullahoma, Tennessee, 37388, United States

  • Vascular Breakthroughs

    RECRUITING

    Plymouth, Massachusetts, 02360, United States

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