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A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
NCT06747117 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DEVICE Indigo Aspiration System
Study Locations (20)
Florida
- University of Florida Shands Hospital — Gainesville
- Radiology and Imaging Specialists — Lakeland
- Baptist Hospital of Miami, Miami Cardiac and Vascular Institute — Miami
Ohio
- TriHealth Good Samaritan Hospital — Cincinnati
- Cleveland Clinic — Cleveland
South Carolina
- Prisma Health Greenville Memorial Hospital — Greenville
- Lexington Medical Center — West Columbia
Texas
- Baylor St. Luke's Medical Center — Houston
- Baylor Scott & White The Heart Hospital - Plano — Plano
Arizona
- HonorHealth Scottsdale Osborn Medical Center — Scottsdale
California
- Community Memorial Hospital — Ventura
Connecticut
- Yale New Haven Hospital — New Haven
Delaware
- Christiana Care Health Services, Inc. — Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-05-18 |
| Est. Completion | 2029-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06747117
The ClinicalTrials.gov registry entry for NCT06747117 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penumbra, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Lower Extremity Acute Limb Ischemia appearing as the primary indexed condition, and to 1 intervention — of which Indigo Aspiration System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06747117 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Ohio, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06747117 about?
NCT06747117 is a clinical study titled "A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)". 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).
What is the current status of trial NCT06747117?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2025-05-18. Estimated completion is 2029-01.
What conditions does trial NCT06747117 study?
This clinical trial studies the following conditions: Lower Extremity Acute Limb Ischemia, LE ALI. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06747117?
The interventions under investigation include: Indigo Aspiration System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06747117?
This trial is sponsored by Penumbra, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06747117 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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