Clinical trial NCT02037932: Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry
Official title: Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Intracranial Aneurysms
Aneurysm
Brain Aneurysm
Keywords: Aneurysm
Brain Aneurysm
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Microvention-Terumo, Inc.
First posted: 2014-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and second-generation MicroVention hydrogel coils for treatment of previously treated or untreated ruptured and unruptured intracranial aneurysms.

Detailed description: This is a prospective, single arm, single center study of patients with ruptured or unruptured saccular aneurysms that are embolized using MicroVention second-generation hydrogel coils and undergo balloon remodeling with the MicroVention Scepter Occlusion Balloon Catheter. Data for each patient will be collected 6 ± 3 months post-procedure for the study.

Eligibility criteria: Inclusion Criteria:

* Patient is 18-80 years of age.
* Patient has a documented, previously treated or untreated saccular intracranial aneurysm, 4- 20 mm unruptured or ruptured, suitable for treatment with balloon assisted coil embolization.
* Target aneurysm has a neck ≥4mm or the largest diameter to neck ratio of 2 or less.
* Patient has a Hunt and Hess Score of 3 or less.
* Patient has a premorbid mRS of 3 or less.
* Patient or patient's legally authorized representative has provided written informed consent.
* Patient is willing to and can comply with study follow-up requirements.

Exclusion Criteria:

* Inability to obtain informed consent.
* Patient is \<18 or \>80 years of age.
* Target aneurysm is dissecting, fusiform, mycotic, or arteriovenous malformation-related.
* Aneurysm that was treated previously with stent-assisted coiling.
* Implantation of the stent after the balloon-assisted coiling or combined stent and balloon assisted coiling.
* Target aneurysm is deemed unsuitable for balloon-assisted coiling by the treating physician prior to the procedure.
* Target aneurysm will be treated with a total coil length comprised of less than 80% second generation MicroVention Hydrogel Coils.
* Balloon-assisted coiling will be performed using a balloon catheter other than the MicroVention Scepter balloon (Scepter C, Scepter XC, any future Scepter configurations).
* Patients in which the target aneurysm is planned not to be coiled in one procedure (i.e. staged procedure).
* Patients with more than one aneurysm that requires treatment. (However, a second small low risk aneurysm that does not require therapy may be allowed.)
* Patients with a life expectancy of ≤ 9 months.

Primary outcomes:
measure: Aneurysm recurrence rate
timeFrame: 3-9 month follow-up
Secondary outcomes:
measure: Occlusion Rate
timeFrame: At immediate post-procedure (Day 1) and 3-9 month follow-up
measure: Number of coils used
timeFrame: At end of study procedure (Day 1)
measure: Total coil length used
timeFrame: At immediate post-procedure (Day 1)
measure: Aneurysm re-treatment rate
timeFrame: 3-9 month follow-up
measure: Aneurysm Bleed and Re-bleed Rate
timeFrame: 3-9 month follow-up
measure: Time of fluoroscopic exposure
timeFrame: At immediate post-procedure (Day 1)
measure: Modified Rankin Score
timeFrame: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up
measure: Device-related serious adverse events
timeFrame: From the study procedure (Day 1) until 3-9 month follow up
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Osama O Zaidat, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: