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
Qualifiers
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 design
Treatments tested in this trial
- Indigo Aspiration System
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov