Clinical trial NCT01407952: Hydrogel Endovascular Aneurysm Treatment Trial
Official title: New Generation Hydrogel Endovascular Aneurysm Treatment Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Aneurysm
Keywords: treatment trial
cerebral aneurysm
randomized
coils
endovascular
HEAT
bare platinum
Hydrogel
Hydrocoil
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: MicroVention, Inc.
First posted: 2011-08-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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 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.

Primary outcomes:
measure: Number of Patients With Aneurysm Recurrence Post Surgery
timeFrame: post surgery to 24 months
Secondary outcomes:
measure: Packing Density
timeFrame: at operation
measure: Clinical Outcome: Modified Rankin Scale (mRS)
timeFrame: 24 months
measure: Number of Participants With Adverse Events Related to the Procedure and/or the Device by Participant at Any Time in the Study.
timeFrame: 24 months
measure: Total Number of Peri-procedural and Post-procedural Adverse Events Related to the Procedure and/or the Device.
timeFrame: 24 months
measure: Number of Patients Who Expired During the Study (Mortality Rate)
timeFrame: 24 months
measure: Number of Participants With Initial Complete Occlusion
timeFrame: at procedure
measure: Number of Patients Who Needed Re-treatment of Target Aneurysm
timeFrame: 24 months
measure: Number of Participants Experiencing a Hemorrhage From Target Aneurysm Post Surgery
timeFrame: 24 months
measure: Number of Participants Who Progressed on the Meyers Scale
timeFrame: 24 months
measure: Number of Participants Experiencing Major Versus Minor Recurrence by 24 Months Follow-up.
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital
state: Arizona
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento
state: California
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Honolulu
country: United States
facility: Queens Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Health
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Consulting Radiologists, LTD
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Trenton
country: United States
facility: Capital Health Regional Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Center
state: Oklahoma
city: Clackamas
country: United States
facility: Kaiser Permanente NW
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Methodist Hospital Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Halifax
country: Canada
facility: Dalhousie Univerisity
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health/McMaster Univeristy
state: Ontario
city: Montreal
country: Canada
facility: CHUM Research Centre
state: Quebec
city: Montreal
country: Canada
facility: McGill Universtiy
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
city: Quebec
country: Canada
facility: CHU de Quebec
Study officials:
affiliation: Mayo Clinic
name: Bernard R Bendok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.