AzTrials
AzTrials

Cerebral AneurysmHEATNCT01407952

Hydrogel Endovascular Aneurysm Treatment Trial

A study testing HydroCoil Embolic System in people with Cerebral Aneurysm, run by Northwestern University at 44 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cerebral Aneurysm
What is being tested?
HydroCoil Embolic System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
44 sitesin 2 countries
Study dates
Apr 2012to Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 34Show fewer
  • 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
  • Myocardial infarction within the past 6 months
  • Cancer likely to cause death within 2 years or less.
  • Subject history indicates high risk of non-compliance (e.g., substance abuse, psychosocial issues, etc.)
  • 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.
  • 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
  • Subject is currently breast feeding, pregnant or plans to become pregnant in the next 2 years.
  • Major surgical procedure or trauma within 30 days prior to randomization
  • The patient is currently enrolled in another clinical study (device or drug).
  • More than one aneurysm needing treatment at the same time.

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States38 sites

  • Albany Medical College

    Albany, New York, 12208

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Maryland

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Kaiser Permanente NW

    Clackamas, Oregon, 07015

  • Cleveland Clinic

    Cleveland, Ohio, 44122

  • Ohio State University

    Columbus, Ohio, 43210

  • UPMC Hamot

    Erie, Pennsylvania, 16507

  • East Carolina University

    Greenville, North Carolina, 27834

  • Queens Medical Center

    Honolulu, Hawaii, 96813

  • Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Lyerly Neurosurgery

    Jacksonville, Florida, 32207

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Louisville

    Louisville, Kentucky, 40202

  • Norton Healthcare

    Louisville, Kentucky, 40207

  • Baptist Cardiac and Vascular Institute

    Miami, Florida, 33176

  • Consulting Radiologists, LTD

    Minneapolis, Minnesota, 55407

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • West Virginia University

    Morgantown, West Virginia, 26508

  • Columbia University

    New York, New York, 10032

  • Christiana Hospital

    Newark, Delaware, 19718

  • Advocate Health

    Oak Lawn, Illinois, 60453

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • St. Joseph's Hospital

    Phoenix, Arizona, 85013

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mercy General Hospital

    Sacramento, California, 95819

  • Kaiser Permanente Sacramento

    Sacramento, California, 95825

  • Washington University

    St Louis, Missouri, 63110

  • SUNY Stony Brook

    Stony Brook, New York, 11794

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • MultiCare Health System

    Tacoma, Washington, 98405

  • Capital Health Regional Medical Center

    Trenton, New Jersey, 08638

Other trials in United States

Canada6 sites

  • Dalhousie Univerisity

    Halifax, Nova Scotia, B3H-3A7

  • Hamilton Health/McMaster Univeristy

    Hamilton, Ontario, L8L 2X2

  • CHUM Research Centre

    Montreal, Quebec, H2L 4M1

  • McGill Universtiy

    Montreal, Quebec, H3A 2B4

  • CHU de Quebec

    Québec, G1J 1Z4

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 0W8

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
HydroCoil Embolic System, Control (bare platinum coils)
Keywords
treatment trial, cerebral aneurysm, randomized, coils, endovascular, HEAT, bare platinum, Hydrogel, Hydrocoil
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroCoil Embolic SystemDevice

    Also called MicroVention, Inc

    HydroCoil Embolic System

  • Control (bare platinum coils)Device

    bare platinum coils

Study groups in NCT01407952
Study groupRoleWhat they receive
HydroCoil Embolic SystemOtherAneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950)
Receives: Device: HydroCoil Embolic System
ControlOtherAneurysm treatment using bare platinum coil(s)
Receives: Device: Control (bare platinum coils)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Aneurysm Recurrence Post Surgery

    Defined as any progression on the Raymond-Roy (RR) Aneurysm Occlusion Scale. The RR scale is such that 1=complete occlusion, 2=residual neck, and 3=residual aneurysm.

    Measured: post surgery to 24 months

Secondary outcomes (10)

  1. Packing Density

    Packing density as measured by volumetric filling of the aneurysm

    Measured: at operation

  2. Clinical Outcome: Modified Rankin Scale (mRS)

    modified rankin scale is a measure of neurological disability, which ranges from 0=no symptoms to 5=severe disability (6=dead).

    Measured: 24 months

  3. Number of Participants With Adverse Events Related to the Procedure and/or the Device by Participant at Any Time in the Study.

    number of participants who experienced any peri-procedural or post-procedural Adverse Event noted to be related to the procedure or device.

    Measured: 24 months

  4. Total Number of Peri-procedural and Post-procedural Adverse Events Related to the Procedure and/or the Device.

    total number of Adverse Events per person that were noted to be related to the procedure and device during the study

    Measured: 24 months

  5. Number of Patients Who Expired During the Study (Mortality Rate)

    all-cause mortality at any time during study follow-up

    Measured: 24 months

  6. Number of Participants With Initial Complete Occlusion

    Raymond-Roy (RR) Scale=1 at procedure The RR scale is such that 1=complete occlusion, 2=residual neck, and 3=residual aneurysm.

    Measured: at procedure

  7. Number of Patients Who Needed Re-treatment of Target Aneurysm

    During the 24 month follow-up, if Aneurysm needed to be re-treated.

    Measured: 24 months

  8. Number of Participants Experiencing a Hemorrhage From Target Aneurysm Post Surgery

    Per the Adverse event log, if a hemorrhage or rupture occurred that was noted to be related to the procedure or device at any point during the 24 month follow-up (not during the operation).

    Measured: 24 months

  9. Number of Participants Who Progressed on the Meyers Scale

    Occlusion (in)stability was determined by progression on the Meyers scale. The Meyer scale is a 6-point grading scale based on the percentage of the aneurysm filled by contrast on DSA. Grade zero indicates complete and total aneurysm occlusion without remnant or in-terstitial filling within the aneurysm. Grade 1 represents greater than 90%volumetric occlusion of the aneurysm based on planar imaging assessment; grade 2, 70%-89% aneurysm occlusion; grade 3,50%-69%; grade 4, 25%-49%; and grade 5, less than 25% volumetric aneurysm occlusion.

    Measured: 24 months

  10. Number of Participants Experiencing Major Versus Minor Recurrence by 24 Months Follow-up.

    Major recurrence is defined as progression on the Raymond-Roy (RR) Scale to 3, or if initial RR was 3, then progression on the Meyers scale. Minor recurrence was defined as a progression on the RR scale to 2.

    The RR scale is a 3 point measure of occlusion, 1=total, 2=residual neck, and 3=residual aneurysm.

    The Meyer scale is a 6-point grading scale based on the percentageof the aneurysm filled by contrast on DSA. Grade zero indicates complete and total aneurysm occlusion without remnant or in-terstitial filling within the aneurysm. Grade 1 represents >90%volumetric occlusion of the aneurysm based on planar imaging assessment; grade 2, 70%-89% aneurysm occlusion; grade 3,50%-69%; grade 4, 25%-49%; and grade 5, <25% volumetric aneurysm occlusion.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01407952
Sponsor's protocol ID
HEAT_protocol1
Acronym
HEAT
Status last verified
Jun 2019
First submitted
12 Jul 2011
Last updated
27 Jun 2019
Data monitoring committee
Yes

Publications

  • Bendok BR, Abi-Aad KR, Ward JD, Kniss JF, Kwasny MJ, Rahme RJ, Aoun SG, El Ahmadieh TY, El Tecle NE, Zammar SG, Aoun RJN, Patra DP, Ansari SA, Raymond J, Woo HH, Fiorella D, Dabus G, Milot G, Delgado Almandoz JE, Scott JA, DeNardo AJ, Dashti SR; HEAT Study Investigators. The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil. Neurosurgery. 2020 May 1;86(5):615-624. doi: 10.1093/neuros/nyaa006.

    PubMed 32078692

Questions about this trial

What is this clinical trial studying?

A study testing HydroCoil Embolic System in people with Cerebral Aneurysm, run by Northwestern University at 44 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Aneurysm Recurrence Post Surgery (time frame: post surgery to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01407952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in