Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Carotid Stenosis
• Age: Between 18 Year(s) - 80 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography.
  2. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
     Symptomatic: =70% stenosis of the common or internal carotid artery by ultrasound or =50% stenosis of the common or internal carotid artery by angiogram
     OR
     Asymptomatic: =70% stenosis of the common or internal carotid artery by ultrasound or =60% stenosis of the common or internal carotid artery by angiogram.
  3. Patient is at least 18 and less than 80 years old.

  
  

You may not be eligible for this study if the following are true:

• 1. Patient has an intracranial tumor.
  2. Patient has an evolving stroke.
  3. Patient had or will have open heart (e.g., CABG), endovascular stent procedure, valve intervention, vascular surgery, other major operation within 30 days of the index procedure.
  4. Female patients who are pregnant or may become pregnant.
  5. Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to ENROUTE stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, statin or contrast media (that can’t be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel or alternative P2Y12 inhibitor.
  6. Patient has a life expectancy <3 years.
  7. Patient has primary, recurrent or metastatic malignancy and does not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
  8. Patient has an unresolved/uncorrected bleeding disorder.
  9. Patient has a known allergy to nitinol.