Actively Recruiting
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
Led by Penumbra Inc. · Updated on 2026-04-27
300
Participants Needed
33
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- Confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with at least 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 planned with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy aspiration tubing
- Informed consent obtained from patient or legally authorized representative according to Institutional Review Board/Ethics Committee requirements
- Patients previously enrolled with a new acute occlusion in the opposite limb may be re-enrolled if more than 30 days have passed since the first procedure
You will not qualify if you...
- Life expectancy less than 1 year
- Target vessel size less than 2 mm
- Target thrombus located in the aorta or isolated profunda artery
- Prior major amputation above the tarsometatarsal joint in the target limb
- Prior minor amputation in the target limb within the past 6 months that is not fully healed or cannot bear weight
- LE ALI caused by dissection, vasculitis, or vessel trauma including iatrogenic causes, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, or foreign bodies
- Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed less than 3 months before index ALI symptoms, or bypass grafts with distal anastomosis below the popliteal artery
- Prior treatment of the current event with thrombolytics or other endovascular or open surgical methods before enrollment
- Pregnancy
- Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
- Other medical, behavioral, or psychological conditions that prevent appropriate consent, participation, compliance with follow-up, or affect study integrity
- Current participation in another investigational drug or device study that could affect this study's results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
Sharp Memorial Hospital
San Diego, California, United States, 92123
Actively Recruiting
3
Community Memorial Hospital
Ventura, California, United States, 93003
Actively Recruiting
4
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
6
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19713
Actively Recruiting
7
Manatee Memorial Hospital
Bradenton, Florida, United States, 34208
Actively Recruiting
8
University of Florida Shands Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
9
Radiology and Imaging Specialists
Lakeland, Florida, United States, 33805
Actively Recruiting
10
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
Miami, Florida, United States, 33176
Actively Recruiting
11
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
12
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
13
Community Hospital
Munster, Indiana, United States, 46321
Actively Recruiting
14
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
15
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
16
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
17
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
18
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
19
Sanger Heart & Vascular Institute
Concord, North Carolina, United States, 28204
Actively Recruiting
20
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Actively Recruiting
21
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Actively Recruiting
23
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
Actively Recruiting
24
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Actively Recruiting
25
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
26
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States, 75093
Actively Recruiting
27
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
28
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
29
Universitätsklinik Leipzig
Leipzig, Germany, 04103
Actively Recruiting
30
Klinikum Stuttgart - Katharinenhospital
Stuttgart, Germany, 70174
Actively Recruiting
31
ASST Degli Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
32
Ospedale Policlinico San Martino, Genova
Genoa, Italy
Actively Recruiting
33
Lausanne University Hospital
Lausanne, Switzerland, 1005
Actively Recruiting
Research Team
M
Marina Mello
CONTACT
J
Jemymah Allen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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