PC400 Coils for Treatment of Intracranial Aneurysms
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSemmes-Murphey Foundation
About this trial
The goal of this prospective, observational study is to evaluate the long-term occlusion rates and safety of the Penumbra PC400 coil in the treatment of ruptured and unruptured intracranial aneurysms in adult subjects ages 18-80.
Specifically, the study aims to analyze rate of death, stroke, neurological death, or rebleeding associated with the treatment of intracranial aneurysm with the PC400 coil.
Participants will undergo standard of care treatment and follow up for their aneurysm treatment, and participating sites will collect procedural and follow up data.
Eligibility criteria
Qualifiers
Subject is ≥ 18 and ≤ 80 years of age.
Subject has a previously untreated, ruptured or unruptured, saccular intracranial aneurysm 5mm or more in diameter for which the clinical decision to treat with Penumbra PC400 embolization coils has been made independent of the decision to enroll the subject in the study described in this protocol.
The decision to undergo the coiling procedure is made independently of and prior to participation in the research.
Subject has a baseline Hunt and Hess Score of I, II, or III.
Disqualifiers
Subject is < 18 or > 80 years of age.
Subject has a baseline Hunt and Hess score of IV or V.
Target aneurysm is dissecting, fusiform, blister-like, mycotic, tumoral, or AVM related.
Target aneurysm maximum diameter is <5mm
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov