LE ALI, Lower Extremity Acute Limb Ischemia
Conditions
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).
Interventions
DEVICEIndigo Aspiration System
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies * Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed \< 3 months prior to index ALI symptom onset, or bypass grafts with a distal anastomosis below the popliteal artery * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Limb Salvage Rate | 30 Days Post-Procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Immediate Post Procedure | Technical success by treated segment 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 |
Countries
Australia, Brazil, Germany, Italy, Malaysia, Switzerland, United States
Contacts
CONTACTMarina Mello
CONTACTJemymah Allen
PRINCIPAL_INVESTIGATORDaniel Clair, MD
Vanderbilt University Medical Center
PRINCIPAL_INVESTIGATORDierk Scheinert, MD
Universitätsklinik Leipzig
Outcome results
None listed