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 - Target thrombus in a saphenous vein bypass graft - 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
HonorHealth Scottsdale Osborn Medical Center
Scottsdale 5313457, Arizona 5551752 85251
Scottsdale 5313457, Arizona 5551752 85251
Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06520
New Haven 4839366, Connecticut 4831725 06520
Christiana Care Health Services, Inc.
Newark 4143861, Delaware 4142224 19713
Newark 4143861, Delaware 4142224 19713
Radiology and Imaging Specialists
Lakeland 4161438, Florida 4155751 33805
Lakeland 4161438, Florida 4155751 33805
Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
OSF Saint Francis Medical Center
Peoria 4905687, Illinois 4896861 61637
Peoria 4905687, Illinois 4896861 61637
Community Hospital
Munster 4924014, Indiana 4921868 46321
Munster 4924014, Indiana 4921868 46321
University of Maryland
Baltimore 4347778, Maryland 4361885 21201
Baltimore 4347778, Maryland 4361885 21201
TriHealth Good Samaritan Hospital
Cincinnati 4508722, Ohio 5165418 45220
Cincinnati 4508722, Ohio 5165418 45220
Prisma Health Greenville Memorial Hospital
Greenville 4580543, South Carolina 4597040 29605
Greenville 4580543, South Carolina 4597040 29605
Jackson-Madison County General Hospital
Jackson 4632595, Tennessee 4662168 38301
Jackson 4632595, Tennessee 4662168 38301
Baylor St. Luke's Medical Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
The Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Milwaukee 5263045, Wisconsin 5279468 53226
More Details
- Status
- Recruiting
- Sponsor
- Penumbra Inc.