A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
Purpose
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
- Lower Extremity Acute Limb Ischemia
- LE ALI
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Patients with lower extremity acute limb ischemia | Device: Indigo Aspiration System |
|
Recruiting Locations
UMass Memorial Medical Center
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
More Details
- Status
- Recruiting
- Sponsor
- Penumbra Inc.