PC400 Coils for Treatment of Intracranial Aneurysms

A vizsgálat adatai

Ki végzi

Semmes-Murphey Foundation

Azonosító

NCT07464847

A regiszteradat frissítve

2026. március 11.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

Penumbra PC400 Coils for Treatment of Medium and Large Sized (5mm or More) Intracranial Aneurysms: A Prospective Multicenter Study

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.

Bevonási feltételek: 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; Subject must be considered by the treating physician to be available for and able to complete all follow-up visits; Subject has not been previously entered into this study.

Kizáró feltételek: Target aneurysm was previously treated via clipping or coiling; Subject is pregnant, breastfeeding, or plans to become pregnant prior to completion of follow-up; Subject is enrolled in another device or drug study in which participation could confound study results; Subject has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device; Subject is at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc; 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; Target aneurysm is deemed by the treating physician to be unsuitable for coiling or unlikely to be successfully treated by endovascular techniques; Target aneurysm has not been confidently determined by the treating physician to be the source of SAH; Planned use of a flow diverter (Surpass, Pipeline, Silk, FRED, p64, etc.) or intrasaccular device (WEB, Artis, Medina, etc.) as a component of the target aneurysm treatment plan; Intended use of a coil-assist stent as a component of the target aneurysm treatment plan, unless stent is used for bailout purposes; Subject has a contraindication to heparin or aspirin; Subject has vascular anatomy/tortuosity preventing access to the target aneurysm; Subject is unable to undergo DSA or DSA is determined unsuitable or outside standard of care by the treating physician; Subject has a serious or life-threatening comorbidity that could confound study results; Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 18 months.

ClinicalTrials.gov NCT07464847