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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

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

ArmDescriptionAssigned Intervention
Patients with lower extremity acute limb ischemia Device: Indigo Aspiration System
  • Device: Indigo Aspiration System
    Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Recruiting Locations

HonorHealth Scottsdale Osborn Medical Center
Scottsdale 5313457, Arizona 5551752 85251

Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06520

Christiana Care Health Services, Inc.
Newark 4143861, Delaware 4142224 19713

Radiology and Imaging Specialists
Lakeland 4161438, Florida 4155751 33805

Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322

OSF Saint Francis Medical Center
Peoria 4905687, Illinois 4896861 61637

Community Hospital
Munster 4924014, Indiana 4921868 46321

University of Maryland
Baltimore 4347778, Maryland 4361885 21201

TriHealth Good Samaritan Hospital
Cincinnati 4508722, Ohio 5165418 45220

Prisma Health Greenville Memorial Hospital
Greenville 4580543, South Carolina 4597040 29605

Jackson-Madison County General Hospital
Jackson 4632595, Tennessee 4662168 38301

Baylor St. Luke's Medical Center
Houston 4699066, Texas 4736286 77030

The Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

Status
Recruiting
Sponsor
Penumbra Inc.

Study Contact

Marina Mello
+14078108634
mmello@penumbrainc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.