PC400 Coils for Treatment of Intracranial Aneurysms

NCT07464847 | Not Yet Recruiting

• 1 other identifier: PC400 GEN II
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Aneurysms; Saccular Aneurysm

Keywords

Intracranial aneurysm; Coiling

Outcome Measures

Primary Outcomes (3)

• Procedure- or disease-related death or major stroke

  Procedure- or disease-related death or major stroke within 30 days of treatment

  30 days post-procedure

• Stroke, neurological death, or rebleeding from target aneurysm

  Major ipsilateral stroke, neurological death or rebleeding from the target aneurysm during the 18-month follow-up period

  18 months post procedure

• Adequate angiographic occlusion

  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).

  18 months post-procedure

Secondary Outcomes (6)

• 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

Other Outcomes (3)

• Procedural duration

  Procedural

• Number of coils

  Procedural

• Adverse events related to the coils/coiling procedure

  Up to 18 months following the procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible subjects presenting to a participating study site will be considered for enrollment. 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmes-Murphey Foundation: lead

Study Sites (1)

Semmes Murphey Clinic

Memphis, Tennessee, 38120, United States

Location

Related Publications (3)

• 3. Mascitelli JR, Polykarpou MF, Patel AA, Kamath AA, Moyle H, Patel AB. Initial experience with Penumbra Coil 400 versus standard coils in embolization of cerebral aneurysms: a retrospective review. J Neurointerv Surg. 2013 Nov;5(6):573-6.

  BACKGROUND

• Berge J, Gariel F, Marnat G, Dousset V. PC400 volumetric coils minimize radiation, reduce procedure time and optimize packing density during endovascular treatment in medium sized cerebral aneurysms. J Neuroradiol. 2016 Feb;43(1):37-42.

  BACKGROUND

• Kulcsár Z, Wanke I, Rüfenacht D, Wetzel SG, Göricke S, Kolia K, Quarfordt S, Calvert J, Hawk H, Baxter B. Safety and effectiveness of large volume coils in the treatment of small aneurysms. J Neurointerv Surg. 2016 Dec;8(12):1260-1263.

  BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nitin Goyal, MD

  Semmes Murphey Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Goyal

CONTACT

901-522-7700; ngoyal@semmes-murphey.com

Olivia House

CONTACT

901-522-7785; ohouse@semmes-murphey.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The IPD will be available following study completion estimated to be in 2029 with no set end date.
• Access Criteria: A designated biostatistician will access study IPD. Access will be established through secure electronic transfer. Following publication, results and supporting information will be established on the ClinicalTrials.gov website.

Locations

US (1)