Hydrogel Endovascular Aneurysm Treatment Trial

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Brief Title

Hydrogel Endovascular Aneurysm Treatment Trial

Official Title

New Generation Hydrogel Endovascular Aneurysm Treatment Trial

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.
    


Study Type

Interventional


Primary Outcome

Number of Patients With Aneurysm Recurrence Post Surgery

Secondary Outcome

 Packing Density

Condition

Cerebral Aneurysm

Intervention

HydroCoil Embolic System

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

600

Start Date

April 2012

Completion Date

March 2018

Primary Completion Date

March 2018

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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Bernard R Bendok, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01407952

Organization ID

HEAT_protocol1


Responsible Party

Principal Investigator

Study Sponsor

Northwestern University

Collaborators

 MicroVention, Inc.

Study Sponsor

Bernard R Bendok, MD, Principal Investigator, Mayo Clinic


Verification Date

June 2019