Lakeland, FLNCT06747117Now EnrollingIRB Ready

Lower Extremity Acute Limb Ischemia Clinical Trial in Lakeland, FL

Access cutting-edge lower extremity acute limb ischemia treatment through this clinical trial at a research site in Lakeland. Study-provided care at no cost to qualified participants.

Sponsored by Penumbra Inc.

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Expert Care in Lakeland

Access lower extremity acute limb ischemia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related lower extremity acute limb ischemia treatment provided free

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Check if you qualify for this lower extremity acute limb ischemia clinical trial in Lakeland, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Lakeland

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Lakeland site if eligible
  4. 4Begin participation

About This Lower Extremity Acute Limb Ischemia Study in Lakeland

The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).

Sponsor: Penumbra Inc.

Who Can Participate

Inclusion Criteria

Age ≥18 years
Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac
Acute occlusion with symptom duration of 14 days or less at presentation
ALI Rutherford Category I, IIa or IIb
First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing
Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements
Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure

Exclusion Criteria

Life expectancy \<1 year
Target vessel size \<2 mm
Target thrombus is in the aorta or isolated profunda artery
Prior major amputation (proximal to the tarsometatarsal joint) in the target limb
Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight
LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies
Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed \< 3 months prior to index ALI symptom onset, or bypass grafts with a distal anastomosis below the popliteal artery
Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment
Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lakeland?

Yes, this clinical trial (NCT06747117) has an active research site in Lakeland, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lower Extremity Acute Limb Ischemia Treatment Options in Lakeland, FL

If you're searching for lower extremity acute limb ischemia treatment options in Lakeland, FL, this clinical trial (NCT06747117) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lakeland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced lower extremity acute limb ischemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lower extremity acute limb ischemia clinical trials near you to find additional studies recruiting in your area.

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