Hydrogel Endovascular Aneurysm Treatment Trial

NCT01407952 | Completed Results DMC

• 1 other identifier: HEAT_protocol1
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 44

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.

Conditions

Cerebral Aneurysm

Keywords

treatment trial; cerebral aneurysm; randomized; coils; endovascular; HEAT; bare platinum; Hydrogel; Hydrocoil

Outcome Measures

Primary Outcomes (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.

  post surgery to 24 months

Secondary Outcomes (10)

• Packing Density

  at operation

• Clinical Outcome: Modified Rankin Scale (mRS)

  24 months

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

  24 months

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

  24 months

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

  24 months

Study Arms (2)

HydroCoil Embolic System

OTHER

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

Device: HydroCoil Embolic System

Control

OTHER

Aneurysm treatment using bare platinum coil(s)

Device: Control (bare platinum coils)

Interventions

HydroCoil Embolic System DEVICE

HydroCoil Embolic System

Also known as: MicroVention, Inc

HydroCoil Embolic System

Control (bare platinum coils) DEVICE

bare platinum coils

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northwestern University: lead
• MicroVention, Inc.: collaborator

Study Sites (44)

St. Joseph's Hospital

Phoenix, Arizona, 85013, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Kaiser Permanente Sacramento

Sacramento, California, 95825, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Queens Medical Center

Honolulu, Hawaii, 96813, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Advocate Health

Oak Lawn, Illinois, 60453, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Norton Healthcare

Louisville, Kentucky, 40207, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Consulting Radiologists, LTD

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Capital Health Regional Medical Center

Trenton, New Jersey, 08638, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Columbia University

New York, New York, 10032, United States

Location

SUNY Stony Brook

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44122, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Kaiser Permanente NW

Clackamas, Oregon, 07015, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16507, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

West Virginia University

Morgantown, West Virginia, 26508, United States

Location

Dalhousie Univerisity

Halifax, Nova Scotia, B3H-3A7, Canada

Location

Hamilton Health/McMaster Univeristy

Hamilton, Ontario, L8L 2X2, Canada

Location

CHUM Research Centre

Montreal, Quebec, H2L 4M1, Canada

Location

McGill Universtiy

Montreal, Quebec, H3A 2B4, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

CHU de Quebec

Québec, G1J 1Z4, Canada

Location

Related Publications (1)

• 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.

  PMID: 32078692 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Bernard Bendok, MD
• Organization: Mayo Clinic

bendok.bernard@mayo.edu

3129269441

Study Officials

• Bernard R Bendok, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: August 2, 2011
• Study Start: April 1, 2012
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 27, 2019
• Results First Posted: June 27, 2019

Record last verified: 2019-06

Locations

US (38); CA (6)