Clinical trial NCT06747117: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
Official title: STRIDE II: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System II
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Extremity Acute Limb Ischemia
LE ALI
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that present with LE ALI who are eligible for mechanical thrombectomy using the Indigo Aspiration System

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).


Eligibility criteria: 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

Primary outcomes:
measure: Target Limb Salvage Rate
timeFrame: 30 Days Post-Procedure
Secondary outcomes:
measure: Technical Success
timeFrame: Immediate Post Procedure
measure: Primary Patency at 30 Days
timeFrame: 30 Days Post-Procedure
measure: Rates of Device-related Major Bleeding
timeFrame: Procedure, 30 Days, and 180 Days Post-Procedure
measure: Rates of Device-related Distal Embolization
timeFrame: During Procedure
measure: Rates of Device-related Serious Adverse Events (SAE)
timeFrame: Procedure, 30 Days, and 180 Days Post-Procedure
measure: Mortality
timeFrame: 30 Days and 180 Days Post-Procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: Vanderbilt University Medical Center
name: Daniel Clair, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Leipzig
name: Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
References: