Trials / Recruiting
RecruitingNCT06747117
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
STRIDE II: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System II
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Penumbra Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Indigo Aspiration System | Mechanical aspiration thrombectomy with the Indigo Aspiration System. |
Timeline
- Start date
- 2025-05-18
- Primary completion
- 2028-06-01
- Completion
- 2029-01-01
- First posted
- 2024-12-24
- Last updated
- 2026-04-01
Locations
28 sites across 5 countries: United States, Australia, Germany, Italy, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06747117. Inclusion in this directory is not an endorsement.