Status:
COMPLETED
Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting
Lead Sponsor:
Jinling Hospital, China
Conditions:
CVD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Severe intracranial atherosclerosis with concomitant stenosis is responsible for approximately 10% of all strokes. Retrospective studies have indicated that up to 50% of patients with a recently sympt...
Detailed Description
Severe intracranial atherosclerosis with concomitant stenosis is responsible for approximately 10% of all strokes. In Asian populations intracranial stenoses are even the most commonly found vascular ...
Eligibility Criteria
Inclusion
- 1: Clinical inclusion criteria
- Subject is ≥18 years old
- Eligible for percutaneous endovascular intervention
- Documented severe (70%) symptomatic intracranial stenosis
- Acceptable candidate for intracranial stenting
- 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
- Subject willing to comply with all specified follow-up evaluations
- 2: Angiographic Inclusion Criteria
- Target lesion located in intracranial internal artery, intracranial vertebral artery, basilar artery or middle cerebral artery
- Target lesion must be symptomatic
- Target lesion diameter stenosis ≥70%
- Reference vessel diameter (RVD): ≥2.0 mm to ≤6.0 mm
- Cumulative target lesion length (area to be treated must be completely coverable by one study stent) ≤30 mm
- Target lesion is presumed accessible by endovascular treatment.
- One non target lesion may be treated in a non target vessel
- Non-target lesion in non-target vessel must be treated with a commercially available stent.
- Treatment of a non target lesion (if performed) must be deemed a clinical angiographic success, without requiring use of unplanned additional stent(s).
- Treatment must be completed prior to treatment of target lesion
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01255852
Start Date
January 1 2011
End Date
July 1 2015
Last Update
September 2 2015
Active Locations (1)
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1
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002