N/A N=600 Randomized Treatment

Hydrogel Endovascular Aneurysm Treatment Trial

Cerebral Aneurysm

Bottom Line

View on ClinicalTrials.gov: NCT01407952 ↗

Enrolled (actual)

600

Serious AEs

21.7%

Results posted

Jun 2019

Primary outcome: Primary: Number of Patients With Aneurysm Recurrence Post Surgery — 11; 41 participants — p=0.002

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: HydroCoil Embolic System (Device); Control (bare platinum coils) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Aneurysm Recurrence Post Surgery	11; 41	0.002 sig
SECONDARY Packing Density	32.5; 24.7	<0.01 sig
SECONDARY Clinical Outcome: Modified Rankin Scale (mRS)	181; 178; 60; 63; 24; 28	0.578
SECONDARY Number of Participants With Adverse Events Related to the Procedure and/or the Device by Participant at Any Time in the Study.	64; 75	0.352
SECONDARY Total Number of Peri-procedural and Post-procedural Adverse Events Related to the Procedure and/or the Device.	233; 228; 44; 63; 19; 8	0.769
SECONDARY Number of Patients Who Expired During the Study (Mortality Rate)	7; 9	0.641
SECONDARY Number of Participants With Initial Complete Occlusion	50; 82	0.003 sig
SECONDARY Number of Patients Who Needed Re-treatment of Target Aneurysm	13; 22	0.162
SECONDARY Number of Participants Experiencing a Hemorrhage From Target Aneurysm Post Surgery	2; 0	0.245
SECONDARY Number of Participants Who Progressed on the Meyers Scale	33; 71	<0.01 sig
SECONDARY Number of Participants Experiencing Major Versus Minor Recurrence by 24 Months Follow-up.	32; 55; 2; 14; 217; 197	<0.01 sig

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Candidates will be ineligible for enrollment in the study if any of the following conditions apply:

Inability to obtain informed consent
Patient is 75 years old
Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting).
Target aneurysm is > 14 mm maximum luminal dimension, 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
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.
Subject history indicates high risk of non-compliance (e.g., substance abuse, psychosocial issues, etc.)
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.
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
Subject is currently breast feeding, pregnant or plans to become pregnant in the next 2 years.
Major surgical procedure or trauma within 30 days prior to randomization
The patient is currently enrolled in another clinical study (device or drug).
More than one aneurysm needing treatment at the same time.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01407952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.