CNV_2019_01 PERFECT

• Research type

  Research Study

• Full title

  Prospective Evaluation to Characterize the Real-World PerFormance of the EMBOVAC Aspiration Catheter for Neurothrombectomy: A Post-Market Clinical Follow-up Trial

• IRAS ID

  286572

• Contact name

  Arnaud Nicolas

• Contact email

  anicolas@its.jnj.com

• Sponsor organisation

  Cerenovus

• Clinicaltrials.gov Identifier

  NCT04531904

• Duration of Study in the UK

  1 years, 3 months, 14 days

• Research summary

  This is a prospective, observational registry that plans to enrol approximately 100 patients at approximately 10 sites in Europe.

  The objective of this study is to assess the efficacy of the EMBOVAC® Aspiration Catheter in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.

  Patients enrolled in this study will be treated for Acute Ischemic Stroke , in other words, a blood clot in the brain. They will be treated using the EMBOVAC aspiration catheter by aspirating the clot out of the vessel. This is a well established treatment for acute ischemic stroke and is currently the standard of care at Charing Cross Hospital.

  During the procedure, angiographic imaging will be collected per pass for subsequent review by an independent Imaging Core Lab. Any clot retrieved during the procedure will be collected and will be sent to Ireland for analysis by an independent Central Lab.

  After the procedure, subjects will be followed for 90 days per the schedule below:
  1. Study procedure
  2. 24 Hour Follow-up (+/- 8 hrs)
  3. 7 Day/Discharge Follow-up
  4. 90 Day Follow-up (+/- 14 days)

  The medical devices used and all treatment related activities (i.e. the tests and procedures) are conducted per standard operating policies at the treating hospital (study site). The conduct of this study does not affect the hospitals standard operating policies and does not impact the patient’s standard of care.
  Study-related activities exclusively consists of the structured collection and evaluation of data; this includes the patient angiographic imaging and the collection of blood clots retrieved from the patient during the procedure.

• REC name

  London - South East Research Ethics Committee

• REC reference

  20/LO/1111

• Date of REC Opinion

  20 Nov 2020

• REC opinion

  Further Information Favourable Opinion