Actively Recruiting
STRIDE II: Study of Indigo13 Aspiration System to Remove Blood Clots in Lower Extremity Acute Limb Ischemia
Led by Penumbra Inc. · Updated on 2026-06-02
300
Participants Needed
37
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Indigo13 Aspiration System in patients with lower extremity acute limb ischemia (LE ALI), a condition where blood flow is blocked in the legs. The study aims to collect clinical evidence on how well this device works to remove blood clots in affected limbs and support limb salvage. This observational study is sponsored by Penumbra Inc. and focuses on patients with a confirmed diagnosis of LE ALI who meet specific clinical criteria. Participants will be treated with the Indigo13 Aspiration System, which uses mechanical aspiration thrombectomy to remove clots. The device is applied as first-line treatment using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing. The study includes patients with acute occlusion symptoms lasting 14 days or less, and those may be re-enrolled if a new acute occlusion occurs in the opposite limb after 30 days. There are no comparator groups as this is an observational evaluation of device performance. Throughout the study, researchers will monitor outcomes such as limb salvage rate 30 days after the procedure, technical success immediately after treatment, and primary vessel patency at 30 days. They will also track device-related complications like bleeding, distal embolization, serious adverse events, and mortality up to 180 days post-procedure. Participants will undergo regular follow-up assessments to evaluate these outcomes, and the study is expected to continue until January 2029.
CONDITIONS
Brief 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 65;18 years
- Confirmed lower limb arterial blockage in the common iliac or below, with at least 2 cm of open artery in the common iliac
- Symptoms of acute occlusion present for 14 days or less
- Rutherford Category I, IIa, or IIb acute limb ischemia
- First treatment with Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy tubing
- Informed consent given by patient or legal representative
- Re-enrollment allowed for new acute occlusion in opposite limb if more than 30 days after first procedure
You will not qualify if you...
- Life expectancy less than 1 year
- Target vessel size smaller than 2 mm
- Thrombus located in the aorta or isolated profunda artery
- Previous major amputation above the mid-foot on the target limb
- Recent minor amputation within 6 months on the target limb not fully healed or unable to bear weight
- Lower extremity acute limb ischemia caused by dissection, vasculitis, vessel trauma, or non-thrombotic material
- Thrombus in vein bypass grafts or recently placed bypass grafts under 3 months old
- Prior treatment of current event with thrombolytics or surgery before enrollment
- Pregnancy
- Allergy or sensitivity to iodinated contrast that cannot be premedicated
- Medical or psychological conditions limiting consent or participation
- Current participation in another investigational drug or device study that could affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo mechanical aspiration thrombectomy using the Indigo Aspiration System to remove blood clots in the lower extremity.
1 procedure visit (in-person)
Duration - Up to 180 days after procedure
Participants are monitored for safety and effectiveness of the procedure, including limb salvage, patency, and device-related events.
Visits at procedure, 30 days, and 180 days post-procedure
Trial Site Locations
Total: 37 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
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
12
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
14
Community Hospital
Munster, Indiana, United States, 46321
Actively Recruiting
15
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
16
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
17
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
18
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
19
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
20
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
21
Sanger Heart & Vascular Institute
Concord, North Carolina, United States, 28204
Actively Recruiting
22
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States, 27607
Actively Recruiting
23
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Actively Recruiting
24
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
25
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Actively Recruiting
26
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
Actively Recruiting
27
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Actively Recruiting
28
William P. Clements Jr. University Hospital
Dallas, Texas, United States, 75235
Actively Recruiting
29
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
30
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States, 75093
Actively Recruiting
31
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
32
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
33
Universitätsklinik Leipzig
Leipzig, Germany, 04103
Actively Recruiting
34
Klinikum Stuttgart - Katharinenhospital
Stuttgart, Germany, 70174
Actively Recruiting
35
ASST Degli Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
36
Ospedale Policlinico San Martino, Genova
Genoa, Italy
Actively Recruiting
37
Lausanne University Hospital
Lausanne, Switzerland, 1005
Actively Recruiting
Research Team
M
Marina Mello
J
Jemymah Allen
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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