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

STRIDE II: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System II

Observational Penumbra Inc. · NCT06747117

This will test whether the Indigo Aspiration System can safely remove clots and restore blood flow in adults with recent (≤14 days) lower‑limb acute ischemia.

Quick facts

Study typeObservational
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorPenumbra Inc. Industry-sponsored
Locations33 sites (Scottsdale, Arizona and 32 other locations)
Trial IDNCT06747117 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with a confirmed lower limb arterial occlusion at the common iliac or below, symptom duration ≤14 days, Rutherford category I–IIb, and suitable target vessel size (≥2 mm) who can receive first‑line treatment with the Indigo system are ideal candidates.

Not a fit: Patients with life expectancy under one year, target thrombus in the aorta or isolated profunda artery, target vessel under 2 mm, prior major amputation, or occlusions older than 14 days are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the device could offer a less invasive way to quickly restore blood flow and reduce the need for more extensive surgery or risk of limb loss.

How similar studies have performed: Percutaneous aspiration thrombectomy and prior observational work with the Indigo system and similar devices have shown promising clot removal and reperfusion results, though randomized comparative data remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Scottsdale, Arizona and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lower Extremity Acute Limb IschemiaLE ALI
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.