Removing leg artery clots with the Indigo Aspiration System for acute lower‑limb ischemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will collect clinical data on adults with confirmed lower extremity acute limb ischemia treated first‑line with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) tubing. Eligible patients have arterial occlusions located at the common iliac or below with symptoms for 14 days or less and Rutherford category I, IIa, or IIb. The trial will record device performance and safety outcomes following the procedure and during follow‑up to build evidence on real‑world use. Data will include procedural success, complications, and clinical course after aspiration thrombectomy.

Why it matters

Who can join: the full rules

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
* Pregnancy
* 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

Where it's running

• HonorHealth Scottsdale Osborn Medical Center
  Scottsdale, Arizona, United States Recruiting
• Sharp Memorial Hospital
  San Diego, California, United States Recruiting
• Community Memorial Hospital
  Ventura, California, United States Recruiting
• University of Colorado Hospital
  Aurora, Colorado, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Christiana Care Health Services, Inc.
  Newark, Delaware, United States Recruiting

Study contacts

• Principal investigator: Daniel Clair, MD — Vanderbilt University Medical Center
• Study coordinator: Marina Mello
• Email: mmello@penumbrainc.com
• Phone: +14078108634

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.