Aneurysm Study of Pipeline in an Observational Registry

TerminadoClinicalTrials.gov

ID: NCT01557036Tipo: OBSERVATIONALInicio: 1 de may de 2012

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.

Elegibilidad

Sexo: ALL

Criterios de inclusión

(All sites, All countries)
At least 1 Pipeline placed for treatment of an ICA
Patient or patient's Legally Authorized Representative (LAR) has signed an IRB- or EC-approved informed consent form, if required
Patient is willing and able to comply with follow-up visits
US) 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
C) 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.
C) Canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter.
F) 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.
F) IA previously treated with unruptured recanalization of the aneurismal sac \> 7 mm, not treatable with conservative treatment.

Criterios de exclusión

Active bacterial infection
A patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated
A patient who has not received dual antiplatelet agents prior to the procedure
Pre-existing stent is in place in the parent artery at the target aneurysm location
Angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing
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.

Intervenciones

device

Pipeline Embolization Device

Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.

Ubicaciones

Clínica La Sagrada Familia

Buenos Aires, Argentina

Patrocinadores

PrincipalMedtronic Neurovascular Clinical Affairs

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