A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)

Penumbra

Status

Not yet enrolling

Conditions

LE ALI

Lower Extremity Acute Limb Ischemia

Treatments

Device: Indigo Aspiration System

Study type

Observational

Funder types

Industry

Identifiers

NCT06747117

CLP 30000

Details and patient eligibility

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).

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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