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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Procedure- or disease-related death or major stroke
Procedure- or disease-related death or major stroke within 30 days of treatment
Time frame
30 days post-procedure2
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
Time frame
18 months post procedure3
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).
Time frame
18 months post-procedureSecondary outcomes
1
30-day Modified Rankin Scale (mRS)
Clinical outcome (mRS) at 30 days (20 - 60 days). Scores range from 0-6, zero = no symptoms, six = dead.
Time frame
30 days post procedure2
18-month Modified Rankin Scale (mRS)
Clinical outcome (mRS) at 18 ± 6 months. Scores range from 0-6, zero = no symptoms, six = dead.
Time frame
18 months post-procedure3
Packing density
Packing density as measured by volumetric filling of the aneurysm immediately post-procedure
Time frame
Immediately post-procedure4
Retreatment rate due to recurrence
Retreatment rate due to recurrence at 18 months
Time frame
18 months post-procedureOther outcomes
1
Procedural duration
Procedural duration (minutes)
Time frame
Procedural2
Number of coils
Mean number of coils
Time frame
Procedural3
Adverse events related to the coils/coiling procedure
Peri-/post-procedural adverse events related to the device and/or the procedure
Time frame
Up to 18 months following the procedureSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: