Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting (APORIAS)

Inclusion Criteria:

• 1: Clinical inclusion criteria

  1. Subject is ≥18 years old
  2. Eligible for percutaneous endovascular intervention
  3. Documented severe (70%) symptomatic intracranial stenosis
  4. Acceptable candidate for intracranial stenting
  5. Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
  6. Subject willing to comply with all specified follow-up evaluations

• 2: Angiographic Inclusion Criteria

  1. Target lesion located in intracranial internal artery, intracranial vertebral artery, basilar artery or middle cerebral artery
  2. Target lesion must be symptomatic
  3. Target lesion diameter stenosis ≥70%
  4. Reference vessel diameter (RVD): ≥2.0 mm to ≤6.0 mm
  5. Cumulative target lesion length (area to be treated must be completely coverable by one study stent) ≤30 mm
  6. Target lesion is presumed accessible by endovascular treatment.
  7. One non target lesion may be treated in a non target vessel
  8. Non-target lesion in non-target vessel must be treated with a commercially available stent.
  9. Treatment of a non target lesion (if performed) must be deemed a clinical angiographic success, without requiring use of unplanned additional stent(s).
  10. Treatment must be completed prior to treatment of target lesion

Exclusion Criteria:

• Contraindication to ASA, or to both clopidogrel and ticlopidine
• Known hypersensitivity to atorvastatin
• Known allergy to stainless steel
• Known allergy to platinum
• Previous treatment of the target vessel with angioplasty
• Previous treatment of the target vessel with stent
• Previous treatment of any non target vessel with stent within 9 months of the index procedure
• Planned endovascular treatment to post index procedure
• Planned or actual target vessel treatment with an unapproved device, directional or rotational intracranial atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
• Cerebral infarction within 1 month prior to the index procedure
• Myocardial infarction within the past 1 month
• Uncontrollable malignant hypertension (>180/110 mmHg) before procedure
• Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or 177 μmol/l)
• Contraindication to ASA, or to both clopidogrel and ticlopidine
• Known hypersensitivity to atorvastatin
• Known allergy to stainless steel
• Known allergy to platinum
• Previous treatment of the target vessel with any stent
• Previous treatment of the target vessel with angioplasty
• Previous treatment of any non-target vessel with any stent within 9 months of the index procedure
• Planned endovascular treatment post-index procedure
• Anticipated treatment with atorvastatin or other statins during the 12 months after the index procedure
• Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure
• Leukopenia (leukocyte count < 3.5 × 109/liter)
• Thrombocytopenia (platelet count < 100,000/mm3)
• Thrombocytosis (> 750,000/mm3)
• Seizure 12 months before procedure
• Intracranial tumor
• Active peptic ulcer or active gastrointestinal (GI) bleeding
• Male or female with known intention to procreate within 12 months after the index procedure
• Positive pregnancy test within 7 days before the index procedure, or lactating
• Life expectancy of less than 24 months due to other medical conditions
• Co-morbid condition(s) that could limit the subject's ability to comply with study follow-up requirements or impact the scientific integrity of the study
• Currently participating in another investigational drug or device study
• Current treatment, or past treatment within 6 months with atorvastatin or other statins
• Angiographic Exclusion Criteria (Visual Estimate)
• Target lesion is a chronic total occlusion (TIMI flow < 1)
• Target lesion is restenotic
• Target lesion is located in a T shaped bifurcation
• Target lesion and/or target vessel proximal to the target lesion is severely calcified
• Target lesion and/or target vessel proximal to the target lesion is severely tortuous
• Target lesion is located within or distal to a > 60° bend in the vessel Target lesion with angiographic presence of probable or definite thrombus