Hydrogel Endovascular Aneurysm Treatment Trial

NCT ID: NCT01407952

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2018-03-31

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.

Conditions

Cerebral Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HydroCoil Embolic System

Aneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950)

Group Type: OTHER

HydroCoil Embolic System

Intervention Type: DEVICE

HydroCoil Embolic System

Control

Aneurysm treatment using bare platinum coil(s)

Group Type: OTHER

Control (bare platinum coils)

Intervention Type: DEVICE

bare platinum coils

Interventions

HydroCoil Embolic System

HydroCoil Embolic System

Intervention Type: DEVICE

Control (bare platinum coils)

bare platinum coils

Intervention Type: DEVICE

Other Intervention Names

MicroVention, Inc

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroVention, Inc.

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Bernard Bendok

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernard R Bendok, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

St. Joseph's Hospital

Phoenix, Arizona, United States

Mercy General Hospital

Sacramento, California, United States

Kaiser Permanente Sacramento

Sacramento, California, United States

Christiana Hospital

Newark, Delaware, United States

Lyerly Neurosurgery

Jacksonville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Queens Medical Center

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Advocate Health

Oak Lawn, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

Norton Healthcare

Louisville, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Consulting Radiologists, LTD

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Capital Health Regional Medical Center

Trenton, New Jersey, United States

Albany Medical College

Albany, New York, United States

Columbia University

New York, New York, United States

SUNY Stony Brook

Stony Brook, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

East Carolina University

Greenville, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, United States

Kaiser Permanente NW

Clackamas, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

UPMC Hamot

Erie, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Methodist Hospital Research Institute

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

MultiCare Health System

Tacoma, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

Dalhousie Univerisity

Halifax, Nova Scotia, Canada

Hamilton Health/McMaster Univeristy

Hamilton, Ontario, Canada

CHUM Research Centre

Montreal, Quebec, Canada

McGill Universtiy

Montreal, Quebec, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

CHU de Quebec

Québec, , Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 32078692 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HEAT_protocol1

Identifier Type: -

Identifier Source: org_study_id