Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 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: June 9, 2014
Last verified: June 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

  Show 42 Study Locations
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: June 9, 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 July 22, 2014