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New device aims to unclog leg arteries safely

NCT ID NCT04663867

Disease control Sponsor: AngioSafe, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new tool called the AngioSafe Peripheral CTO Crossing System in 79 people with blocked leg arteries (peripheral artery disease). The goal was to see if the device could safely help doctors place a guidewire through the blockage. The study measured how often the device worked without causing serious problems right after the procedure.

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

79 people

The number who actually took part.

Started

Feb 2021

Finished

Jun 2023

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

22 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.

Inclusion Criteria: * Able and willing to comply with protocol requirements and sign informed consent form * ≥ 22 years of age * Peripheral arterial disease defined by Rutherford Clinical Classification (Category 2-5) * Peripheral artery disease in target extremity is confirmed by imaging (catheter angiography, computed tomographic angiography (CTA), and/or magnetic resonance angiography (MRA)) Angiographic Inclusion Criteria: * Target lesion in native de novo common femoral artery (CFA), superficial femoral artery (SFA), and/or popliteal artery * Vessel diameter(s) for target lesion is ≥ 3.0mm and ≤ 10mm * Subject's target lesion is a severely stenosed segment of ≤ 300 mm that involves the CTO(s) * Subject's target lesion involves at least one CTO that is 99-100% stenosed * Subject has at least one vessel with run-off to the foot Exclusion Criteria: * Systemic infection or an infection in extremity of target lesion * Target lesion within native vein or synthetic vessel grafts or in stent occlusion * Planned intervention in the contralateral limb during the study * Planned intervention in the target limb of the inflow vessels during the study * Planned intervention of lower extremities after study procedure within 30-day follow-up visit * Coagulopathy or bleeding diatheses, thrombocytopenia with platelet count less than 50,000/μl, or INR \> 1.7 * Antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated * Allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated * Allergy to nickel, titanium, urethane, nylon, or silicone * History of myocardial infarction within 30 days prior to enrollment/consent * History of stroke within 30 days prior to enrollment/consent * Chronic kidney disease (CKD) of stage 4 or greater based on an Estimated Glomerular Filtration Rate (eGFR) \<30ml/Min, unless the subject is on chronic renal replacement therapy * Hemoglobin levels \<10g/dL verified by a lab test no older than 14 days prior to enrollment, unless the subject has a history of chronic anemia at a stable level, no recent bleeding diathesis or history of blood transfusion in the last six weeks * Pregnant or nursing, for females of child-bearing potential (\< 50 years of age) * Participating in another interventional research study that may interfere with study endpoints * Prior major amputation (above ankle) in target extremity * Acute limb ischemia (ALI) * Prior unsuccessful attempt to cross the target lesion * Subject has had a procedure on the target limb or contralateral limb within 7 days * Subject has had a procedure on the target limb or contralateral limb within the past 30 days and is unstable

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Conditions

The condition(s) this trial relates to.

arterial occlusion peripheral arterial disease peripheral ischemia

As listed by the trial registrant

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

Peripheral arterial disease Peripheral artery occlusion

Contacts and locations

Locations

  • Adventist Health St. Helena

    St. Helena, California, 94754, United States

  • American Endovascular & Amputation Prevention

    West Orange, New Jersey, 07052, United States

  • Baylor Scott & White, The Heart Hospital Plano

    Plano, Texas, 75093, United States

  • Cardiovascular Associated of East Texas

    Tyler, Texas, 75701, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

  • Coastal Vascular & Interventional, PLLC

    Pensacola, Florida, 32504, United States

  • Dignity Health - Chandler Regional Medical Center

    Chandler, Arizona, 85224, United States

  • Mercy Hospital South

    St Louis, Missouri, 63128, United States

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52801, United States

  • Palm Vascular Centers

    Miami Beach, Florida, 33140, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • VA North Texas Medical Center

    Dallas, Texas, 75216, United States

  • Vascular Care Connecticut

    Darien, Connecticut, 06820, United States

  • Vascular Care Group

    Wellesley, Massachusetts, 06820, United States

  • Vascular Solutions of North Carolina

    Cary, North Carolina, 27518, United States

  • Wellmont Cardiology Services

    Kingsport, Tennessee, 37660, United States

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