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

Penumbra

Status: Completed

Conditions: LE ALI; Lower Extremity Acute Limb Ischemia

Treatments: Device: Indigo Aspiration System

Study type: Observational

Funder types: Industry

Identifiers

NCT04144959

CLP 15549

Details and patient eligibility

About

The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient age ≥ 18
• Patient presents with acute (≤14 days) occlusion of lower limb artery(ies) (below inguinal ligament)
• Patient with a Rutherford Category I, IIa or IIb score
• Frontline treatment with Indigo Aspiration System
• Informed consent is obtained from either patient or legally authorized representative (LAR)

Exclusion criteria

• Life expectancy <1 year
• Vessel size <2 mm
• LE ALI secondary to dissections, vasculitis, and/or target vessel trauma
• Amputation in the ipsilateral limb
• Pregnancy or positive pregnancy test according to site specific standards of care (only required for women of child bearing potential, serum or urine acceptable)
• Absolute contraindication to contrast administration
• Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
• Currently participating in an investigational drug or device clinical trial that may confound the study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Trial design

119 participants in 1 patient group

Patients with lower extremity acute limb ischemia

Treatment:

Device: Indigo Aspiration System