STRIDE II: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System II
Penumbra Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 requirem…
Interventions
- DeviceIndigo Aspiration System
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Locations (33)
- HonorHealth Scottsdale Osborn Medical CenterScottsdale, Arizona
- Sharp Memorial HospitalSan Diego, California
- Community Memorial HospitalVentura, California
- University of Colorado HospitalAurora, Colorado
- Yale New Haven HospitalNew Haven, Connecticut
- Christiana Care Health Services, Inc.Newark, Delaware