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

Not yet recruiting

• Conditions: Lower Extremity Acute Limb Ischemia; LE ALI

• Registration Number: NCT06747117
• Lead Sponsor: Penumbra Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Study Start: 2025-02
• Primary Completion: 2028-06
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Limb Salvage Rate	30 Days Post-Procedure

Secondary Outcome Measures

Name	Time	Method
Technical Success	Immediate Post Procedure	Technical success defined as Thromboaspiration in Peripheral Ischemia (TIPI) 2/3 flow immediately post procedure by physician visual assessment of intraprocedural angiography
Primary Patency at 30 Days	30 Days Post-Procedure
Rates of Device-related Major Bleeding	Procedure, 30 Days, and 180 Days Post-Procedure
Rates of Device-related Distal Embolization	During Procedure
Rates of Device-related Serious Adverse Events (SAE)	Procedure, 30 Days, and 180 Days Post-Procedure
Mortality	30 Days and 180 Days Post-Procedure	All cause mortality at 30 and 180 days