Penumbra PC400 Coils for Treatment of Medium and Large Sized (5mm or More) Intracranial Aneurysms: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Procedure- or disease-related death or major stroke
研究概览
简要总结
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.
详细描述
Endovascular treatment has become the primary approach for intracranial aneurysms, offering improved safety and reduced recanalization rates. Despite advancements in flow diversion and intrasaccular devices, coiling remains a cornerstone therapy. However, aneurysmal recurrence due to regrowth or coil compaction continues to be a significant concern, with recurrence observed in about 20% of cases, leading to potential rebleeding and treatment challenges.
The Penumbra PC400 coil (Penumbra Inc., Alameda, CA, USA) addresses these concerns by offering 400% more volume per unit length than traditional 0.010-inch coils. This design also reduces procedure and fluoroscopy times, improving overall efficiency. Several retrospective reports have highlighted its advantages in packing density, procedure time, and cost-effectiveness.1,2,3 However, there is a lack of high-level prospective data to support these findings.
The goal of the present study is to determine occlusion rates and safety when Penumbra PC400 coils are used in the treatment of ruptured or unruptured medium and large sized (5mm or more) intracranial aneurysms.
Up to 100 patients ≥ 18 and ≤ 80 years presenting with ruptured or unruptured saccular aneurysms who meet all eligibility criteria will be enrolled. Enrolled subjects must be treated with Penumbra PC400 coils used in any combination comprising a minimum of 80% total coil length used.
The primary safety endpoint is procedure- or disease-related death or major stroke within 30 days of treatment or major ipsilateral stroke, neurological death or rebleeding from the target aneurysm during the 18-month follow-up period. The primary efficacy endpoint is Adequate angiographic occlusion at 18 ± 6 months without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm. This will be assessed by an imaging core lab using digital subtraction angiograms (DSA).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 was previously treated via clipping or coiling.
- •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 known, untreatable hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device.
- •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 at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc.
- •Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 18 months.
- •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.
结局指标
主要结局
Procedure- or disease-related death or major stroke
时间窗: 30 days post-procedure
Procedure- or disease-related death or major stroke within 30 days of treatment
Stroke, neurological death, or rebleeding from target aneurysm
时间窗: 18 months post procedure
Major ipsilateral stroke, neurological death or rebleeding from the target aneurysm during the 18-month follow-up period
Adequate angiographic occlusion
时间窗: 18 months post-procedure
Adequate angiographic occlusion at 18 ± 6 months without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm. This will be assessed by the core lab using digital subtraction angiograms (DSA).
次要结局
- 30-day Modified Rankin Scale (mRS)(30 days post procedure)
- 18-month Modified Rankin Scale (mRS)(18 months post-procedure)
- Packing density(Immediately post-procedure)
- Retreatment rate due to recurrence(18 months post-procedure)
- Angiographic occlusion at 18 months(18 months post-procedure)
- Occlusion stability at 18 months(18 months post-procedure)