Hydrogel Endovascular Aneurysm Treatment Trial

Cerebral Aneurysm Clinical Trial

— HEAT  

Official title:

New Generation Hydrogel Endovascular Aneurysm Treatment Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407952
• Other study ID #: HEAT_protocol1
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: March 2018

Study information

• Verified date: June 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• HydroCoil Embolic System
HydroCoil Embolic System
• Control (bare platinum coils)
bare platinum coils

Locations

Country	Name	City	State
Canada	Dalhousie Univerisity	Halifax	Nova Scotia
Canada	Hamilton Health/McMaster Univeristy	Hamilton	Ontario
Canada	CHUM Research Centre	Montreal	Quebec
Canada	McGill Universtiy	Montreal	Quebec
Canada	CHU de Quebec	Quebec
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
United States	Albany Medical College	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Maryland	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Kaiser Permanente NW	Clackamas	Oregon
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	UPMC Hamot	Erie	Pennsylvania
United States	East Carolina University	Greenville	North Carolina
United States	Queens Medical Center	Honolulu	Hawaii
United States	Methodist Hospital Research Institute	Houston	Texas
United States	Lyerly Neurosurgery	Jacksonville	Florida
United States	Mayo Clinic	Jacksonville	Florida
United States	Norton Healthcare	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	Consulting Radiologists, LTD	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Columbia University	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	Advocate Health	Oak Lawn	Illinois
United States	Oklahoma University Health Sciences Center	Oklahoma City	Oklahoma
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mayo Clinic	Rochester	Minnesota
United States	Kaiser Permanente Sacramento	Sacramento	California
United States	Mercy General Hospital	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	SUNY Stony Brook	Stony Brook	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	MultiCare Health System	Tacoma	Washington
United States	Capital Health Regional Medical Center	Trenton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	MicroVention, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Packing Density	Packing density as measured by volumetric filling of the aneurysm	at operation
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Patients Who Expired During the Study (Mortality Rate)	all-cause mortality at any time during study follow-up	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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