STRIDE II

• Research type

  Research Study

• Full title

  STRIDE II: A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System

• IRAS ID

  367005

• Contact name

  Dominic Howard

• Contact email

  dominic.howard@ouh.nhs.uk

• Sponsor organisation

  Penumbra Inc.

• Clinicaltrials.gov Identifier

  NCT06747117

• Duration of Study in the UK

  1 years, 8 months, 0 days

• Research summary

  This study concerns a serious medical condition called acute limb ischemia.
  This occurs when blood suddenly stops flowing through the vessels in the legs, which can damage tissue.
  One possible treatment is to remove the blood clot using a CE certified device called the Indigo™ aspiration system. This system helps to clear blocked vessels so that blood can flow again. The aim is to protect tissue, prevent the situation from worsening, and help the patient recover.
  The purpose of this study is to verify the safety and effectiveness of this treatment as per standard of care.
  The Indigo system is a medical device authorized in the United States (by the FDA) and in Europe (CE certification). The device has UK approval under their own CE marking.
  Up to 300 patients in approximately 50 hospitals worldwide will participate in this study.
  The study will last approximately 4 years. Each patient will be followed for 6 months, with visits or calls scheduled:
  - upon discharge from the hospital (or after 7 days, whichever comes first)
  - 30 days after the procedure
  - 180 days (6 months) after the procedure
  

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  26/EM/0105

• Date of REC Opinion

  1 Jun 2026

• REC opinion

  Further Information Favourable Opinion