Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Northwestern University
Sponsor:
Collaborator:
MicroVention, Inc
Information provided by (Responsible Party):
Bernard Bendok, Northwestern University
ClinicalTrials.gov Identifier:
NCT01407952
First received: July 12, 2011
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cerebral Aneurysm
Device: HydroCoil Embolic System
Device: Control (bare platinum coils)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New Generation Hydrogel Endovascular Aneurysm Treatment Trial

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Aneurysm recurrence at any point during follow-up. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Defined as any progression on the Raymond Aneurysm Occlusion Scale or the Meyers Aneurysm Occlusion Scale.


Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

    Packing density as measured by volumetric filling of the aneurysm Clinical outcome at 18 - 24 months (mRS). Peri-procedural and post-procedural adverse events related to the procedure and/or the device.

    Mortality rate,Initial Complete occlusion, Aneurysm re-treatment, hemorrhage from target aneurysm during follow-up, Aneurysm occlusion stability, Major versus minor recurrence.



Estimated Enrollment: 600
Study Start Date: April 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HydroCoil Embolic System
Aneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950)
Device: HydroCoil Embolic System
HydroCoil Embolic System
Other Name: MicroVention, Inc
Control
Aneurysm treatment using bare platinum coil(s)
Device: Control (bare platinum coils)
bare platinum coils

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01407952

Contacts
Contact: Byron Yip 312-503-3904 byip@nmff.org
Contact: Bernard R Bendok, MD 3126950494 bbendok@nmff.org

  Hide Study Locations
Locations
United States, Arizona
St. Joseph's Hospital Recruiting
Phoenix, Arizona, United States, 85013
Contact: Cheryl Kelly, RN       cheryl.kelly@dignityhealth.org   
Principal Investigator: Cameron McDougall, MD         
United States, California
Mercy General Hospital Recruiting
Sacramento, California, United States, 95819
Contact: George Luh, MD    916-961-6920    george.luh@dignityhealth.org   
Contact: Isabel Reyes    (916) 453-4114    isabel.reyes3@dignityhealth.org   
Principal Investigator: George Luh, MD         
Kaiser Permanente Sacramento Recruiting
Sacramento, California, United States, 95825
Contact: Jonathan Hartman, MD    916-973-5490    jonathan.hartman@kp.org   
Contact: Ashena Varani    916-973-6134    ashena.x.varani@kp.org   
Principal Investigator: Jonathan Hartman, MD         
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Sudhakar Satti, MD    302-733-2658    ssatti@christianacare.org   
Contact: Andrea Squire    302-733-2658    asquire@christianacare.org   
Principal Investigator: Sudhakar Satti, MD         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Jessie Sperrazza    904-953-9494    sperrazza.jessie@mayo.edu   
Contact: Dale Gamble    904-953-9612    gamble.dale@mayo.edu   
Principal Investigator: Rabih Tawk, MD         
Baptist Cardiac and Vascular Institute Recruiting
Miami, Florida, United States, 33176
Contact: Sarah Orendorff-Alegre, RN    786-596-5974    SarahO@baptisthealth.net   
Principal Investigator: Guilherme Dabus, MD         
United States, Hawaii
Queens Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Sung Lee, MD    808-691-7152    sblee@queens.org   
Contact: Denise Dittrich    808-691-4428    ddittrich@queens.org   
Principal Investigator: Sung Lee, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Byron Yip    312-695-2179    byip@nmff.org   
Principal Investigator: Bernard Bendok, MD         
Advocate Health Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Thomas Grobelny, MD    847-430-6108    thomas.grobelny@advocatehealth.com   
Contact: Diane Lelo    708-684-4698    diane.lelo@advocatehealth.com   
Principal Investigator: Thomas Grobelny, MD         
United States, Kentucky
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40207
Contact: Shervin Dashti, MD    502-394-6390    Shervin.Dashti@nortonhealthcare.org   
Contact: Robyn McLean    502-629-5250    Robyn.McLean@nortonhealthcare.org   
Principal Investigator: Shervin Dashti, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Carly Stokum    410-328-0191    cstokum@umm.edu   
Principal Investigator: Gaurav Jindal, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Colin Gorman    617-726-9143    cgorman@partners.org   
Principal Investigator: Albert Yoo, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Aditya Pandey, MD    734-615-4486    adityap@med.umich.edu   
Contact: Karen Frisch    734 232 4843    kfrisch@med.umich.edu   
Principal Investigator: Aditya Pandey, MD         
McLaren Flint Recruiting
Flint, Michigan, United States, 48532
Contact: Andrew Xavier, MD    810-342-2590    axavier@med.waye.edu   
Contact: Melissa Szemites    810-342-4071    melissa.szemites@mclaren.org   
Principal Investigator: Andrew Xavier, MD         
United States, Minnesota
Consulting Radiologists, LTD Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Jennifer Fease    612-863-5053    jen.fease@crlmed.com   
Principal Investigator: Josser Delgado, MD         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ramachandra Tummala, MD    612-845-2677    tumm0011@umn.edu   
Contact: Kathleen Miller    612-203-2459    mill4109@umn.edu   
Principal Investigator: Ramachandra Tummala, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: David Kallmes, MD    501-266-3350    kallmes.david@mayo.edu   
Contact: Beth Connelly    507.538.3928    connelly.beth@mayo.edu   
Principal Investigator: David Kallmes, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Christopher Moran, MD    314-362-5949    moranc@mir.wustl.edu   
Contact: Robin Haverman    314-747-1624    havermanr@wustl.edu   
Principal Investigator: Christopher Moran, MD         
United States, New Jersey
Capital Health Regional Medical Center Recruiting
Trenton, New Jersey, United States, 08638
Contact: Jillian Scavone, PhD    609-815-7675    jscavone@capitalhealth.org   
Contact: Cynthia Lewis-Diaz, RN, MHA    609-394-6287    cdiaz@capitalhealth.org   
Principal Investigator: Erol Veznedaroglu, MD         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Margaret Czerwinski, RN    518-262-0034    czerwim@mail.amc.edu   
Principal Investigator: Alan Boulos, MD         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Virginia Cox, MPA, RN    212-305-3349    vc94@mail.cumc.columbia.edu   
Principal Investigator: Sean Lavine, MD         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10067
Contact: Athos Patsalides, MD    212-746-2821    atp9002@med.cornell.edu   
Contact: Melissa Ricketts    212-746-7373    mdr2001@med.cornell.edu   
Principal Investigator: Athos Patsalides, MD         
SUNY Stony Brook Recruiting
Stony Brook, New York, United States, 11794
Contact: Dawn Madigan, RN    631-444-8121    dawn.madigan@stonybrookmedicine.edu   
Contact: Marlene Baumeiser, RN    631-444-1610    marlene.baumeister@stonybrookmedicine.edu   
Principal Investigator: Henry Woo, MD         
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Mark Villwock, MS    315-464-5502      
Principal Investigator: Eric Deshaies, MD         
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Kristin JoAnn Wainwright, RN    252-744-5608    wainwrightk@ecu.edu   
Principal Investigator: Robert James, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44122
Contact: Jennifer Turczyk    216-444-5604    turczyj@ccf.org   
Principal Investigator: Ferdinand Hui, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Eric Sauvageau, MD    614-366-6572    Eric.Sauvageau@osumc.edu   
Contact: Kathy Jelinek    614-688-6853    Kathryn.Jelinek@osumc.edu   
Principal Investigator: Eric Sauvageau, MD         
United States, Oklahoma
Oklahoma University Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Steven Hoover, MD    405-271-4113    Steven-Hoover@ouhsc.edu   
Contact: Bradley Hightower    405-271-4658    Bradley-Hightower@ouhsc.edu   
Principal Investigator: Steven Hoover, MD         
United States, Oregon
Kaiser Permanente NW Recruiting
Clackamas, Oregon, United States, 07015
Contact: Jeremy Fields, MD    503-571-3802    Jeremy.D.Fields@kp.org   
Contact: Christina Carlson    503-571-6181    Christina.A.Carlson@kpchr.org   
Principal Investigator: Jeremy Fields, MD         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Sarah Jamieson, RN    503-494-7222    rosssar@ohsu.edu   
Principal Investigator: Stan Barnwell, MD         
United States, Pennsylvania
UPMC Hamot Recruiting
Erie, Pennsylvania, United States, 16507
Contact: Ruth Fries    814-877-6741    friesra@upmc.edu   
Principal Investigator: Cordell Preciado, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jabbour Pascal, MD    215-955-7000    pascal.jabbour@jefferson.edu   
Contact: Pamela Tremarki    215-955-3687    pamela.tremarki@jefferson.edu   
Principal Investigator: Pascal Jabbour, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Mahesh Jayaraman, MD    401-444-5184    mjayaraman@lifespan.org   
Contact: Elizabeth Morrell    401.444.2277    emorrell@lifespan.org   
Principal Investigator: Mahesh Jayaraman, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Adrian Parker    843-792-3164    parkerad@musc.edu   
Principal Investigator: M. Imran Chaudry, MD         
United States, Texas
Methodist Hospital Research Institute Terminated
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Avery Evans, MD    434-924-7558    aje5u@virginia.edu   
Contact: Claire McKinley    434-924-4023    tkt3f@hscmail.mcc.virginia.edu   
Principal Investigator: Avery Evans, MD         
United States, Washington
MultiCare Health System Recruiting
Tacoma, Washington, United States, 98405
Contact: Janey Barnhart    253-403-7258    Meredith.Barnhart@multicare.org   
Contact: Mallory Wall-Tweten    253-403-5273    Mallory.Wall-Tweten@multicare.org   
Principal Investigator: Alison Nohara, MD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26508
Contact: Jennifer Domico    304-598-6930    domicoj@wvuhealthcare.com   
Principal Investigator: Jeffrey Carpenter, MD         
Canada, Nova Scotia
Dalhousie Univerisity Recruiting
Halifax, Nova Scotia, Canada, B3H-3A7
Contact: Jai Shankar, MD    (902) 473-5448    shivajai1@gmail.com   
Contact: Judith Jarrett    (902) 473-5220    judith.jarrett@cdha.nshealth.ca   
Principal Investigator: Jai Shankar, MD         
Canada, Ontario
Hamilton Health/McMaster Univeristy Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Paula Klurfan, MD    905.527.4322 ext 44698    klurfan@gmail.com   
Contact: Michael Bennardo    905.527.4322 ext 44155    bennardo@hhsc.ca   
Principal Investigator: Paula Klurfan, MD         
Canada, Quebec
McGill Universtiy Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Maria Cortes, MD    +1 514-398-1908    maria.cortesnino@mcgill.ca   
Contact: Winnie Poon    +1 514-398-5903    winnie.poon@mcgill.ca   
Principal Investigator: Maria Cortes, MD         
CHUM Research Centre Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Suzanne Nolet    514-890-8000 ext 26359    Suzanne.Nolet@crchum.qc.ca   
Principal Investigator: Jean Raymond, MD         
Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Ruth Whelan    306-966-8187    ruth.whelan@usask.ca   
Principal Investigator: Michael Kelly, MD         
Canada
CHU de Quebec Recruiting
Quebec, Canada, G1J 1Z4
Contact: Genevieve Milot, MD    418.649.5894    gmilot@sympatico.ca   
Contact: Annette Hache    418.649.5892    annette.hache.cha@ssss.gouv.qc.ca   
Principal Investigator: Genevieve Milot, MD         
Sponsors and Collaborators
Northwestern University
MicroVention, Inc
Investigators
Principal Investigator: Bernard R Bendok, MD Northwestern University
  More Information

No publications provided

Responsible Party: Bernard Bendok, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT01407952     History of Changes
Other Study ID Numbers: HEAT_protocol1
Study First Received: July 12, 2011
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
treatment trial
cerebral aneurysm
randomized
coils
endovascular
HEAT
bare platinum
Hydrogel
Hydrocoil

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 26, 2014