NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
| NCT ID | NCT06747117 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Penumbra Inc. |
| Condition | Lower Extremity Acute Limb Ischemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-05-18 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-05-18 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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
Contact & Investigator
Daniel Clair, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT06747117 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lower Extremity Acute Limb Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06747117 currently recruiting?
Yes, NCT06747117 is actively recruiting participants. Contact the research team at mmello@penumbrainc.com for enrollment information.
Where is the NCT06747117 trial being conducted?
This trial is being conducted at Scottsdale, United States, San Diego, United States, Ventura, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT06747117 clinical trial?
NCT06747117 is sponsored by Penumbra Inc.. The principal investigator is Daniel Clair, MD at Vanderbilt University Medical Center. The trial plans to enroll 300 participants.