Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms

NCT02657772 | Completed

• 1 other identifier: HP-00055046
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to assess the safety and efficacy rates of the treatment of small intracranial aneurysms with Stryker Neurovascular's Target® 360 Ultra coils which are a type of platinum coils used to occlude aneurysms.

Conditions

Intracranial Aneurysms

Keywords

Target Ultra coils; small aneurysms

Outcome Measures

Primary Outcomes (1)

• Target Aneurysm Recurrence (TAR)

  Target Aneurysm Recurrence (TAR) - defined as clinically relevant recurrence resulting in: target aneurysm re-intervention, rupture/re-rupture, and/or death from unknown cause as assessed at 9-18 months post procedure.

  9-18 months from baseline/procedure date

Secondary Outcomes (3)

• Residual Aneurysm assessment using modified Raymond Scale

  9-18 months from baseline/procedure date

• Modified Rankin Scale

  Baseline, 1 Day post procedure, 3- 28 days post procedure, 3-9 months, 9-18 months from baseline/procedure date

• Technical procedural success

  Procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be between 18 and 80 years of age (inclusive)and have a documented untreated intracranial aneurysm, less than or equal to 5 mm, ruptured or unruptured, for which Ultra® coils are treatment options, and for which primary coiling treatment is planned to be completed during a single procedure (i.e., no "staged" treatment). Preliminary intracranial stent placement and/or use of an intracranial endoluminal balloon device as adjunctive therapy is allowed.

You may qualify if:

• Patient is between 18 and 80 years of age (inclusive).
• Patient has a documented untreated intracranial aneurysm less than or equal to 5.0 mm in maximal dimension, ruptured or unruptured, suitable for embolization with coils.
• Target® Ultra coils may be used.
• Target aneurysm can be completely or nearly completely coiled at index procedure (No staged treatment procedures) without anticipated need for any target aneurysm reintervention after 72 hours of the index procedure. If a stent is to be placed during a separate preliminary procedure, then screening and enrollment for the coiling procedure must take place after the stenting procedure is completed.
• Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
• Patient (or patient's legally authorized representative) has provided written informed consent.
• Patient is willing and able to comply with protocol follow-up requirements.

You may not qualify if:

• Patient is \<18 or \>80 years old.
• Target aneurysm is felt by the physician operator to be mycotic or clearly dissecting in etiology.
• Target aneurysm is \>5.0 mm maximum luminal dimension.
• Target aneurysm has been previously treated by surgery or endovascular therapy.
• Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
• Patient presents as Hunt and Hess grade V for a ruptured aneurysm.
• Patient has known hypersensitivity to platinum, tungsten, nickel, stainless steel or structurally related compounds found in Target® Ultra coils.
• Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.
• Patients who are unable to complete scheduled follow up assessments at the enrolling center due to limited life expectancy (\<24 months), comorbidities or geographical considerations.
• Patients with Moya-Moya disease, brain arteriovenous malformation(s), significant atherosclerotic stenosis, tortuousity or other conditions preventing access to the target aneurysm.
• Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion on the investigator.
• Female patient has a positive pregnancy assessment at baseline, breastfeeding patient, or patient who plans to become pregnant within the 18 months following coiling.
• The following comorbidities that may confound results: (a) organ failure of kidney (b) uncorrectable coagulation abnormality.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Stryker Neurovascular: collaborator

Study Sites (6)

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

WellStar Research Institute

Marietta, Georgia, 30060, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Geisinger medical center

Danville, Pennsylvania, 17822, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Jindal G, Almardawi R, Gupta R, Colby GP, Schirmer CM, Satti SR, Pukenas B, Hui FK, Caplan J, Miller T, Cherian J, Aldrich F, Kibria G, Simard JM; ULTRA Study Investigators. Target Ultra and Nano coils in the endovascular treatment of small intracranial aneurysms (ULTRA Registry). J Neurosurg. 2022 Jun 24;138(1):233-240. doi: 10.3171/2022.5.JNS2296. Print 2023 Jan 1.

  PMID: 35901755 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Gaurav Jindal, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology, Neurosurgery, Neurology

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 18, 2016
• Study Start: November 1, 2013
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)