A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPenumbra Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients that present with LE ALI who are eligible for mechanical thrombectomy using the Indigo Aspiration System
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Indigo Aspiration System
DeviceMechanical aspiration thrombectomy with the Indigo Aspiration System.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients with lower extremity acute limb ischemia1 intervention
Trial outcomes
Primary outcomes
1
Target Limb Salvage Rate
Time frame
30 Days Post-ProcedureSecondary outcomes
1
Technical Success
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
Time frame
Immediate Post Procedure2
Primary Patency at 30 Days
Time frame
30 Days Post-Procedure3
Rates of Device-related Major Bleeding
Time frame
Procedure, 30 Days, and 180 Days Post-Procedure4
Rates of Device-related Distal Embolization
Time frame
During ProcedureSponsors and contacts
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Source ClinicalTrials.gov