Hydrogel Endovascular Aneurysm Treatment Trial

Completed · Not applicable

Conditions studied: Cerebral Aneurysm

In brief

This research study is being done to test the effectiveness of a new generation FDA approved device for treating aneurysms compared to the current standard device for endovascular aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of minimally invasive surgery, which is performed on blood vessels. The technique involves the introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery found near the groin. The catheter is then maneuvered through the body to the location of the aneurysm in the brain using image guidance. Coils are delivered into the aneurysm through the catheters. Once the coils are delivered in the aneurysm, they are detached from the catheter. This is repeated until enough coils fill the aneurysm, blocking the blood flow to the aneurysm. The body responds by forming blood clots around the coil(s), which helps block the flow of blood into the aneurysm and keeps the vessel from rupturing or leaking. This study will compare the study device to the standard bare platinum coil to see which is better at preventing future rupturing or leaking. The study device is called the HydroCoil Embolization System and this study is a post-market clinical trial. About 600 subjects from multiple institutions will take part in this study.

Key facts

Study ID

NCT01407952

Run by

Northwestern University

People needed

600

Starts

2012-04-01

Expected to finish

2018-03-01

Last updated by the study team

2019-06-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidates for this study must meet the following criteria to be enrolled in the study:
• Patient is between 18 and 75 years of age (inclusive).
• Patient has a documented untreated intracranial saccular aneurysm 3-14 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
• Patients presenting with a HUNT and HESS Grade 0-3 or improving to such a grade before treatment
• Any type of bare platinum coils and HydroCoil ® Coils are treatment options (all shapes allowed).
• Patient or next of kin or person with appropriate power of attorney has provided written informed consent.
• Patient is willing and available for study follow-up visits
• Patient has not been previously entered into this Study

You may not qualify if…

• Candidates will be ineligible for enrollment in the study if any of the following conditions apply:
• Inability to obtain informed consent
• Patient is < 18 or > 75 years old
• Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting).
• Target aneurysm is > 14 mm maximum luminal dimension, < 3 mm maximum luminal dimension
• Target aneurysm has been previously clipped or coiled
• Target aneurysm is in the physician's estimate unlikely to be successfully treated by endovascular techniques.
• Patient has known hypersensitivity to platinum, nickel, stainless steel or structurally related compounds found in HydroCoil®, HydroSoft®, HydroFrame® Coils and/or bare platinum coils.
• Baseline Hunt and Hess scale 4 or 5 for ruptured aneurysms
• Intended use of a flow diverting stent (e.g. pipeline)
• Subject has concurrent intracranial pathology, e.g.
• Moyamoya
• Vasculitis documented by biopsy results
• AVMs
• AV fistulas
• Significant atherosclerotic disease (i.e. symptomatic and or >50% narrowing of the parent arteries necessary to traverse in order to coil the target aneurysm)
• Intracranial Hematoma (unrelated to the target aneurysm)
• Brain tumors
• Vascular tortuosity and other conditions preventing access to target aneurysm
• Subject has serious co-morbidities that could confound the study results:
• Uncontrolled hypertension
• Uncorrectable coagulation abnormality
• Contraindications for heparin, aspirin or clopidogrel
• Uncontrolled Diabetes Mellitus
• Organ failure of kidney, liver, heart, or lung

Where it is running

• St. Joseph's Hospital — Phoenix, Arizona, United States
• Mercy General Hospital — Sacramento, California, United States
• Kaiser Permanente Sacramento — Sacramento, California, United States
• Christiana Hospital — Newark, Delaware, United States
• Lyerly Neurosurgery — Jacksonville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Baptist Cardiac and Vascular Institute — Miami, Florida, United States
• Queens Medical Center — Honolulu, Hawaii, United States
• Northwestern University — Chicago, Illinois, United States
• Advocate Health — Oak Lawn, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Norton Healthcare — Louisville, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Consulting Radiologists, LTD — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Capital Health Regional Medical Center — Trenton, New Jersey, United States
• Albany Medical College — Albany, New York, United States
• Columbia University — New York, New York, United States
• SUNY Stony Brook — Stony Brook, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• East Carolina University — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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