Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Aneurysm
• Intervention / Treatment: Device: HydroCoil Embolic System; Device: Control (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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1J 1Z4
    • CHU de Québec
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H-3A7
      • Dalhousie Univerisity
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health/McMaster Univeristy
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM Research Centre
    • Montreal, Quebec, Canada, H3A 2B4
      • McGill Universtiy
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • University of Saskatchewan
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital
  • California
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Sacramento
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Jacksonville, Florida, United States, 32207
      • Lyerly Neurosurgery
    • Miami, Florida, United States, 33176
      • Baptist Cardiac and Vascular Institute
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Queens Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Health
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
    • Louisville, Kentucky, United States, 40207
      • Norton Healthcare
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Consulting Radiologists, LTD
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • Trenton, New Jersey, United States, 08638
      • Capital Health Regional Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • New York, New York, United States, 10032
      • Columbia University
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Health Sciences Center
  • Oregon
    • Clackamas, Oregon, United States, 07015
      • Kaiser Permanente NW
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • UPMC Hamot
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Hospital Research Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Washington
    • Tacoma, Washington, United States, 98405
      • Multicare Health System
  • West Virginia
    • Morgantown, West Virginia, United States, 26508
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HydroCoil Embolic System; Aneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950)	Device: HydroCoil Embolic System; HydroCoil Embolic System; Other Names: MicroVention, Inc
Other: Control; Aneurysm treatment using bare platinum coil(s)	Device: Control (bare platinum coils); bare platinum coils

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	post surgery to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Packing Density	Packing density as measured by volumetric filling of the aneurysm	at operation
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).	24 months
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.	24 months
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	24 months
Number of Patients Who Expired During the Study (Mortality Rate)	all-cause mortality at any time during study follow-up	24 months
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.	at procedure
Number of Patients Who Needed Re-treatment of Target Aneurysm	During the 24 month follow-up, if Aneurysm needed to be re-treated.	24 months
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).	24 months
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.	24 months
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.	24 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: MicroVention, Inc.
• Investigators: Principal Investigator: Bernard R Bendok, MD, Mayo Clinic

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: August 1, 2011
• First Posted (Estimate): August 2, 2011

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: endovascular; randomized; treatment trial; cerebral aneurysm; coils; HEAT; bare platinum; Hydrogel; Hydrocoil
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: HEAT_protocol1