Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry (GELATIN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical College of Wisconsin
Sponsor:
Collaborator:
Microvention-Terumo, Inc.
Information provided by (Responsible Party):
Osama Zaidat, MD, MSc, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT02037932
First received: January 14, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Intracranial Aneurysms
Aneurysm
Brain Aneurysm
Device: Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Aneurysm recurrence rate [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occlusion Rate [ Time Frame: At immediate post-procedure (Day 1) and 3-9 month follow-up ] [ Designated as safety issue: No ]
    Angiographic occlusion of the aneurysm will be adjudicated using immediate post-procedure and 3-9 month follow-up angiography.

  • Number of coils used [ Time Frame: At end of study procedure (Day 1) ] [ Designated as safety issue: No ]
  • Total coil length used [ Time Frame: At immediate post-procedure (Day 1) ] [ Designated as safety issue: No ]
  • Aneurysm re-treatment rate [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: No ]
  • Aneurysm Bleed and Re-bleed Rate [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: Yes ]
    Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.

  • Time of fluoroscopic exposure [ Time Frame: At immediate post-procedure (Day 1) ] [ Designated as safety issue: Yes ]
    Total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coil embolization procedure.

  • Modified Rankin Score [ Time Frame: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up ] [ Designated as safety issue: No ]
    Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.

  • Device-related serious adverse events [ Time Frame: From the study procedure (Day 1) until 3-9 month follow up ] [ Designated as safety issue: Yes ]
    Procedural and post-procedural serious adverse events related to the device and/or procedure will be captured and recorded at the end of the procedure and until the patient has completed the 3-9 month follow-up.


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Balloon Assisted Coiling
Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
Device: Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
Other Names:
  • MicroVention hydrogel coils
  • MicroVention Scepter C
  • MicroVention Scepter XC

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037932

Contacts
Contact: Alicia C Castonguay, PhD 414-805-5439 acastonguay@mcw.edu

Locations
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Osama O Zaidat, MD, MS    414-805-5219      
Principal Investigator: Osama O Zaidat, MD, MS         
Sub-Investigator: Brian-Fred Fitzsimmons, MD         
Sub-Investigator: John Lynch, MD         
Sub-Investigator: Marc Lazarro, MD         
Sponsors and Collaborators
Osama Zaidat, MD, MSc
Microvention-Terumo, Inc.
Investigators
Principal Investigator: Osama O Zaidat, MD, MS Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Osama Zaidat, MD, MSc, Professor of Neurology, Neurosurgery, & Radiology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02037932     History of Changes
Other Study ID Numbers: 00021229
Study First Received: January 14, 2014
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical College of Wisconsin:
Aneurysm
Brain Aneurysm

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014