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Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01407952
Recruitment Status : Completed
First Posted : August 2, 2011
Results First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
MicroVention, Inc.
Information provided by (Responsible Party):
Bernard Bendok, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cerebral Aneurysm
Interventions Device: HydroCoil Embolic System
Device: Control (bare platinum coils)
Enrollment 600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Period Title: Overall Study
Started 297 303
Completed 251 266
Not Completed 46 37
Arm/Group Title HydroCoil Embolic System Control Total
Hide Arm/Group Description

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils

 Total of all reporting groups
Overall Number of Baseline Participants 297 303 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 297 participants 303 participants 600 participants
56.5  (11.5) 56.9  (10.3) 56.7  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 303 participants 600 participants
Female
238
  80.1%
236
  77.9%
474
  79.0%
Male
59
  19.9%
67
  22.1%
126
  21.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 303 participants 600 participants
Hispanic or Latino
243
  81.8%
247
  81.5%
490
  81.7%
Not Hispanic or Latino
50
  16.8%
48
  15.8%
98
  16.3%
Unknown or Not Reported
4
   1.3%
8
   2.6%
12
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 303 participants 600 participants
American Indian or Alaska Native
4
   1.3%
3
   1.0%
7
   1.2%
Asian
5
   1.7%
9
   3.0%
14
   2.3%
Native Hawaiian or Other Pacific Islander
2
   0.7%
1
   0.3%
3
   0.5%
Black or African American
32
  10.8%
27
   8.9%
59
   9.8%
White
243
  81.8%
247
  81.5%
490
  81.7%
More than one race
7
   2.4%
8
   2.6%
15
   2.5%
Unknown or Not Reported
4
   1.3%
8
   2.6%
12
   2.0%
1.Primary Outcome
Title Number of Patients With Aneurysm Recurrence Post Surgery
Hide Description 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.
Time Frame post surgery to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 251 266
Measure Type: Number
Unit of Measure: participants
11 41
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments A intent to treat analysis was performed, using multiple imputation methods.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.32
Confidence Interval (2-Sided) 95%
1.36 to 3.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Chi-squared test statistic with one degree of freedom=17.37
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.97
Confidence Interval (2-Sided) 95%
1.99 to 7.92
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Packing Density
Hide Description Packing density as measured by volumetric filling of the aneurysm
Time Frame at operation
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with both imaging data (to determine aneurysm size), and coil information (length, number, and type used)
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 238 237
Mean (Standard Deviation)
Unit of Measure: density as expressed as a percentage
32.5  (14.8) 24.7  (10.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Clinical Outcome: Modified Rankin Scale (mRS)
Hide Description modified rankin scale is a measure of neurological disability, which ranges from 0=no symptoms to 5=severe disability (6=dead).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on participants with any post procedural follow-up.
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 287 292
Measure Type: Count of Participants
Unit of Measure: Participants
No symptoms (mRS=0)
181
  63.1%
178
  61.0%
No significant disability (mRS=1)
60
  20.9%
63
  21.6%
Slight disability (mRS=2)
24
   8.4%
28
   9.6%
Moderate disability (mRS=3)
13
   4.5%
10
   3.4%
Moderately severe disability (mRS=4)
2
   0.7%
0
   0.0%
Severe disability (mRS=5)
0
   0.0%
4
   1.4%
Expired (mRS=6)
7
   2.4%
9
   3.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.578
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Adverse Events Related to the Procedure and/or the Device by Participant at Any Time in the Study.
Hide Description number of participants who experienced any peri-procedural or post-procedural Adverse Event noted to be related to the procedure or device.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 297 303
Measure Type: Count of Participants
Unit of Measure: Participants
64
  21.5%
75
  24.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.352
Comments [Not Specified]
Method Chi-squared
Comments Chi-squared test statistic with one degree of freedom = 0.865
5.Secondary Outcome
Title Total Number of Peri-procedural and Post-procedural Adverse Events Related to the Procedure and/or the Device.
Hide Description total number of Adverse Events per person that were noted to be related to the procedure and device during the study
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 297 303
Measure Type: Count of Participants
Unit of Measure: Participants
No events
233
  78.5%
228
  75.2%
One event
44
  14.8%
63
  20.8%
Two events
19
   6.4%
8
   2.6%
Three events
1
   0.3%
4
   1.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.769
Comments [Not Specified]
Method Cochran-Armitage Trend Test
Comments [Not Specified]
6.Secondary Outcome
Title Number of Patients Who Expired During the Study (Mortality Rate)
Hide Description all-cause mortality at any time during study follow-up
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 297 303
Measure Type: Count of Participants
Unit of Measure: Participants
7
   2.4%
9
   3.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.641
Comments [Not Specified]
Method Chi-squared
Comments Chi-square test statistic with one degree of freedom=0.217
7.Secondary Outcome
Title Number of Participants With Initial Complete Occlusion
Hide Description Raymond-Roy (RR) Scale=1 at procedure The RR scale is such that 1=complete occlusion, 2=residual neck, and 3=residual aneurysm.
Time Frame at procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Raymond-Roy Scale recorded at procedure
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 281 290
Measure Type: Count of Participants
Unit of Measure: Participants
50
  17.8%
82
  28.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments chi-square test statistic with one degree of freedom=8.82
8.Secondary Outcome
Title Number of Patients Who Needed Re-treatment of Target Aneurysm
Hide Description During the 24 month follow-up, if Aneurysm needed to be re-treated.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
participants with available followup
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 251 266
Measure Type: Count of Participants
Unit of Measure: Participants
13
   5.2%
22
   8.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments [Not Specified]
Method Chi-squared
Comments Chi-squared test statistic with one degree of freedom=1.955
9.Secondary Outcome
Title Number of Participants Experiencing a Hemorrhage From Target Aneurysm Post Surgery
Hide Description 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).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 297 303
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.7%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants Who Progressed on the Meyers Scale
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 251 266
Measure Type: Count of Participants
Unit of Measure: Participants
33
  13.1%
71
  26.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Chi-squared
Comments Chi-squared test statistic with one degree of freedom=14.743
11.Secondary Outcome
Title Number of Participants Experiencing Major Versus Minor Recurrence by 24 Months Follow-up.
Hide Description

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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description:

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
Overall Number of Participants Analyzed 251 266
Measure Type: Count of Participants
Unit of Measure: Participants
Major recurrence
32
  12.7%
55
  20.7%
Minor recurrence
2
   0.8%
14
   5.3%
No major/minor recurrence
217
  86.5%
197
  74.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HydroCoil Embolic System, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Adverse event data was collected until 18-24 month visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HydroCoil Embolic System Control
Hide Arm/Group Description

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

HydroCoil Embolic System: HydroCoil Embolic System

Aneurysm treatment using bare platinum coil(s)

Control (bare platinum coils): bare platinum coils
All-Cause Mortality
HydroCoil Embolic System Control
Affected / at Risk (%) Affected / at Risk (%)
Total   7/297 (2.36%)      9/303 (2.97%)    
Hide Serious Adverse Events
HydroCoil Embolic System Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/297 (20.54%)      69/303 (22.77%)    
Blood and lymphatic system disorders     
Anemia †  1/297 (0.34%)  1 2/303 (0.66%)  2
Cardiac disorders     
Arrythmia †  1/297 (0.34%)  1 2/303 (0.66%)  2
Cardiac Arrest †  0/297 (0.00%)  0 1/303 (0.33%)  1
Cardiomyopathy, non-schemic †  1/297 (0.34%)  1 1/303 (0.33%)  1
Coronary artery disease †  1/297 (0.34%)  1 0/303 (0.00%)  0
Pericardial effusion †  1/297 (0.34%)  1 1/303 (0.33%)  1
Ear and labyrinth disorders     
Vertigo †  1/297 (0.34%)  1 1/303 (0.33%)  1
Eye disorders     
Hemianopsia †  0/297 (0.00%)  0 2/303 (0.66%)  2
Scotoma †  0/297 (0.00%)  0 1/303 (0.33%)  1
Visual disturbance †  1/297 (0.34%)  1 0/303 (0.00%)  0
Gastrointestinal disorders     
Nausea †  0/297 (0.00%)  0 1/303 (0.33%)  1
Infections and infestations     
Leukocytosis †  0/297 (0.00%)  0 1/303 (0.33%)  1
Meningitis †  1/297 (0.34%)  1 0/303 (0.00%)  0
Sepsis †  0/297 (0.00%)  0 1/303 (0.33%)  1
Urinary tract infection †  1/297 (0.34%)  1 0/303 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fracture left-femur †  1/297 (0.34%)  1 0/303 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer †  1/297 (0.34%)  1 1/303 (0.33%)  1
Lymphoma †  0/297 (0.00%)  0 1/303 (0.33%)  1
Nervous system disorders     
Altered mental status †  1/297 (0.34%)  1 0/303 (0.00%)  0
Amaurosis fugax †  1/297 (0.34%)  1 0/303 (0.00%)  0
Aneurysm, left ICA ophthalmic †  1/297 (0.34%)  1 0/303 (0.00%)  0
Concussion †  1/297 (0.34%)  1 0/303 (0.00%)  0
Confusion †  0/297 (0.00%)  0 1/303 (0.33%)  1
Cranial nerve palsy †  0/297 (0.00%)  0 1/303 (0.33%)  1
Headache †  4/297 (1.35%)  5 5/303 (1.65%)  5
Hemorrhage, intraventicular †  1/297 (0.34%)  1 0/303 (0.00%)  0
Hydrocephalus †  8/297 (2.69%)  9 4/303 (1.32%)  4
Intracranial aneurysm, ruptured †  3/297 (1.01%)  3 6/303 (1.98%)  6
Intracranial hemorrhage, non-specified †  0/297 (0.00%)  0 1/303 (0.33%)  1
Intracranial hemorrhage, subarachnoid †  2/297 (0.67%)  2 1/303 (0.33%)  1
Intracranial, hemorrhage, subdural †  0/297 (0.00%)  0 2/303 (0.66%)  2
Intracranial hypertension †  1/297 (0.34%)  1 0/303 (0.00%)  0
Loss of consciousness †  0/297 (0.00%)  0 1/303 (0.33%)  1
Memory loss †  1/297 (0.34%)  1 0/303 (0.00%)  0
Paresis †  1/297 (0.34%)  1 2/303 (0.66%)  2
Parasthesia †  2/297 (0.67%)  2 0/303 (0.00%)  0
Seizure †  7/297 (2.36%)  9 0/303 (0.00%)  0
Stroke †  15/297 (5.05%)  16 11/303 (3.63%)  11
Transient ischemic attach †  0/297 (0.00%)  0 1/303 (0.33%)  1
Psychiatric disorders     
Depression †  1/297 (0.34%)  1 0/303 (0.00%)  0
Renal and urinary disorders     
Cerebral salt wasting †  0/297 (0.00%)  0 1/303 (0.33%)  1
Respiratory, thoracic and mediastinal disorders     
Apnea †  1/297 (0.34%)  1 0/303 (0.00%)  0
Dyspnea †  1/297 (0.34%)  1 0/303 (0.00%)  0
Pneumonia †  2/297 (0.67%)  2 1/303 (0.33%)  2
Respiratory failure †  1/297 (0.34%)  1 3/303 (0.99%)  3
Surgical and medical procedures     
Air embolism †  0/297 (0.00%)  0 1/303 (0.33%)  1
Coil herniation †  1/297 (0.34%)  1 0/303 (0.00%)  0
Coil prolapse †  1/297 (0.34%)  1 1/303 (0.33%)  1
Groin hematoma †  0/297 (0.00%)  0 1/303 (0.33%)  1
Procedural Thrombosis †  1/297 (0.34%)  1 0/303 (0.00%)  0
Vascular disorders     
Aortic dissection †  1/297 (0.34%)  1 0/303 (0.00%)  0
Arteriovenous fistula †  1/297 (0.34%)  1 0/303 (0.00%)  0
Carotid artery dissection †  0/297 (0.00%)  0 2/303 (0.66%)  2
Hypertensive urgency †  0/297 (0.00%)  0 1/303 (0.33%)  1
Psedudoaneurysm, cerebral †  1/297 (0.34%)  1 0/303 (0.00%)  0
Retroperitonial hemorrhage †  1/297 (0.34%)  1 0/303 (0.00%)  0
Vasospasm †  11/297 (3.70%)  16 17/303 (5.61%)  19
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
HydroCoil Embolic System Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   118/297 (39.73%)      140/303 (46.20%)    
Eye disorders     
Visual Disturbance †  17/297 (5.72%)  17 30/303 (9.90%)  31
General disorders     
Other † [1]  70/297 (23.57%)  105 86/303 (28.38%)  111
Nervous system disorders     
Headache †  38/297 (12.79%)  49 50/303 (16.50%)  53
Parasthesia † [2]  8/297 (2.69%)  9 14/303 (4.62%)  14
Vascular disorders     
Vasospasm †  15/297 (5.05%)  15 18/303 (5.94%)  18
†
Indicates events were collected by systematic assessment
[1]
All other adverse events that did not meet the 3% threshold individually. (e.g. Anemia, Dyspnea, Rash)
[2]
Numbness in face, arms, legs
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Bernard Bendok, MD
Organization: Mayo Clinic
Phone: 3129269441
EMail: bendok.bernard@mayo.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bernard Bendok, Northwestern University
ClinicalTrials.gov Identifier: NCT01407952    
Other Study ID Numbers: HEAT_protocol1
First Submitted: July 12, 2011
First Posted: August 2, 2011
Results First Submitted: March 31, 2019
Results First Posted: June 27, 2019
Last Update Posted: June 27, 2019