Hydrogel Endovascular Aneurysm Treatment Trial



Status:Active, not recruiting
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - 75
Updated:2/22/2018
Start Date:April 2012
End Date:October 2018

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New Generation Hydrogel Endovascular Aneurysm Treatment Trial

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.

Your part in this study will last up to 24 months and will involve 6 visits (1 baseline visit
before your surgery, the surgical procedure and 4 follow-up visits). These visits will occur
at the same time as the visits you would receive as standard of care after your surgery.

If you are in this study, you will be placed in one of two study groups by chance using a
process similar to the flip of a coin. This process is called randomization. Neither you nor
the study staff will select the group you will be in. One group, the control group, will have
their aneurysm treated by the bare platinum coils during their endovascular procedure. The
other group, the study group will receive coils from the HydroCoil Embolization System. Both
groups will receive the same standard of care and follow-up, but during the surgery different
types of coils will be used.

Inclusion Criteria:

Candidates for this study must meet the following criteria to be enrolled in the study:

1. Patient is between 18 and 75 years of age (inclusive).

2. Patient has a documented untreated intracranial saccular aneurysm 3-14 mm diameter
angiographic lumen, ruptured or unruptured, suitable for embolization with coils.

3. Patients presenting with a HUNT and HESS Grade 0-3 or improving to such a grade before
treatment

4. Any type of bare platinum coils and HydroCoil ® Coils are treatment options (all
shapes allowed).

5. Patient or next of kin or person with appropriate power of attorney has provided
written informed consent.

6. Patient is willing and available for study follow-up visits

7. Patient has not been previously entered into this Study

Exclusion Criteria:

Candidates will be ineligible for enrollment in the study if any of the following
conditions apply:

1. Inability to obtain informed consent

2. Patient is < 18 or > 75 years old

3. Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting).

4. Target aneurysm is > 14 mm maximum luminal dimension, < 3 mm maximum luminal dimension

5. Target aneurysm has been previously clipped or coiled

6. Target aneurysm is in the physician's estimate unlikely to be successfully treated by
endovascular techniques.

7. Patient has known hypersensitivity to platinum, nickel, stainless steel or
structurally related compounds found in HydroCoil®, HydroSoft®, HydroFrame® Coils
and/or bare platinum coils.

8. Baseline Hunt and Hess scale 4 or 5 for ruptured aneurysms

9. Intended use of a flow diverting stent (e.g. pipeline)

10. 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

11. 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

- Myocardial infarction within the past 6 months

- Cancer likely to cause death within 2 years or less.

12. Subject history indicates high risk of non-compliance (e.g., substance abuse,
psychosocial issues, etc.)

13. Subject has a known history contraindicating contrast dye or iodine that cannot be
pre-medicated prior to coiling procedure (vs. sensitivity which can be safely
controlled by antihistamine, steroid, etc.). Medical clearance will be needed for this
issue.

14. Patients who are unable to complete scheduled follow up assessments at the enrolling
center due to limited life expectancy (<2 years), co-morbidities or geographical
considerations

15. Subject is currently breast feeding, pregnant or plans to become pregnant in the next
2 years.

16. Major surgical procedure or trauma within 30 days prior to randomization

17. The patient is currently enrolled in another clinical study (device or drug).

18. More than one aneurysm needing treatment at the same time.
We found this trial at
39
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Ferdinand Hui, MD
Phone: 216-444-5604
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Joshua Hirsch, MD
Phone: 617-726-9143
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Boston, MA
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Rabih Tawk, MD
Phone: 904-953-3062
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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8900 North Kendall Drive
Miami, Florida 33176
Principal Investigator: Guilherme Dabus, MD
Phone: 786-596-5974
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Miami, FL
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Ramachandra Tummala, MD
Phone: 612-845-2677
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Sean Lavine, MD
Phone: 212-305-3349
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Hormozd Bozorgchami, MD
Phone: 503-494-7222
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Mahesh Jayaraman, MD
Phone: 401-444-5184
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Alan Boulos, MD
Phone: 518-262-0034
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Aditya Pandey, MD
Phone: 734-615-4486
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Gaurav Jindal, MD
Phone: 410-328-0191
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: M. Imran Chaudry, MD
Phone: 843-792-3164
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Avery Evans, MD
Phone: 434-924-7558
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Sameer Ansari, MD
Phone: 312-926-9445
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Clackamas, Oregon 07015
Principal Investigator: Jeremy Fields, MD
Phone: 503-571-3802
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Ciaran Powers, MD
Phone: 614-366-6572
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Erie, Pennsylvania 16507
Principal Investigator: Charles Romero, MD
Phone: 814-877-6329
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Hilal Kanaan, MD
Phone: 252-744-5608
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Halifax, Nova Scotia
Principal Investigator: Jai Shankar, MD
Phone: (902) 473-5448
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Sung Lee, MD
Phone: 808-691-7152
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Houston, TX
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Jacksonville, Florida 32207
Principal Investigator: Eric Sauvageau, MD
Phone: 904-388-6518
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Louisville, Kentucky 40207
Principal Investigator: Shervin Dashti, MD
Phone: 502-394-6390
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Robert James, MD
Phone: 502-852-2612
University of Louisville The University of Louisville is a state supported research university located in...
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Minneapolis, Minnesota 55407
Principal Investigator: Josser Delgado, MD
Phone: 612-863-5053
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Jeffrey Carpenter, MD
Phone: 304-598-6930
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Newark, Delaware 19718
Principal Investigator: Sudhakar Satti, MD
Phone: 302-733-2658
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Oak Lawn, Illinois 60453
Principal Investigator: Thomas Grobelny, MD
Phone: 847-430-6108
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Oklahoma City, Oklahoma 73104
Principal Investigator: Steven Hoover, MD
Phone: 405-271-4113
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Pascal Jabbour, MD
Phone: 215-955-7000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85013
Principal Investigator: Cameron McDougall, MD
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Rochester, Minnesota 55905
Principal Investigator: David Kallmes, MD
Phone: 501-266-3350
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Sacramento, California 95819
Principal Investigator: George Luh, MD
Phone: 916-961-6920
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6600 Bruceville Road
Sacramento, California 95823
(916) 688-2000
Principal Investigator: Jonathan Hartman, MD
Phone: 916-973-5490
Kaiser Permanente - Sacramento At the Kaiser Permanente South Sacramento Medical Center, you and your...
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Saint Louis, Missouri 63110
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Stony Brook, New York 11794
Principal Investigator: Henry Woo, MD
Phone: 631-444-8121
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750 East Adams Street
Syracuse, New York 13210
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Principal Investigator: Dennis Wang, MD
Phone: 253-403-7258
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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Trenton, New Jersey 08638
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