Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Neurovascular Clinical Affairs
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
(All sites, All countries)
1. At least 1 Pipeline placed for treatment of an ICA
2. Patient or patient's Legally Authorized Representative (LAR) has signed an IRB- or EC-approved informed consent form, if required
3. Patient is willing and able to comply with follow-up visits
4US) Subjects who are age 22 or higher 5US) IA of at least 10 mm in maximum dimension along the internal carotid artery between the petrous and superior hypophyseal segments
4C) In Canada, the Pipeline™ Embolization Device is intended for use with or without embolic coils for the treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping.
5C) Canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter.
4F) Unruptured IA, saccular or fusiform with an aneurysm sac diameter \> 15mm and not treatable with other current therapies ( EVT with coils with or without assisting system (intracranial stent) or balloon remodeling, or surgery) due to its specific morphology.
5F) IA previously treated with unruptured recanalization of the aneurismal sac \> 7 mm, not treatable with conservative treatment.
You may not be if
1. Active bacterial infection
2. A patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated
3. A patient who has not received dual antiplatelet agents prior to the procedure
4. Pre-existing stent is in place in the parent artery at the target aneurysm location
5. Angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing
6. Acutely ruptured aneurysm, defined as rupture of the target aneurysm Each site should refer to their country specific Instructions for Use/Approval(France) to determine final eligibility into the ASPIRe Registry.
