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Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

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: NCT02378883
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arteriovenous Malformations
Intervention Device: Apollo™ Onyx™ Delivery Micro Catheter
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title APOLLO
Hide Arm/Group Description The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Period Title: Enrollment
Started 121 [1]
Completed 112 [2]
Not Completed 9
Reason Not Completed
Subject did not meet Inclusion criteria             6
Attempt to use Apollo was not performed             3
[1]
Participants consented and assessed for eligibility
[2]
Attempted with study device - intent to treat population
Period Title: Discharge
Started 112
Completed 112
Not Completed 0
Period Title: 30 Day Follow-Up
Started 112
Completed [1] 106
Not Completed 6
Reason Not Completed
Withdrawal by Subject             1
Physician Decision             2
Missed Visit             2
Death             1
[1]
Includes 66 subjects with no tip retained. Subjects eligible to exit study per protocol.
Period Title: 12 Months Follow-Up
Started [1] 46 [2]
Completed 41
Not Completed 5
Reason Not Completed
Lost to Follow-up             3
Death             2
[1]
As per protocol only 46 subjects were eligible for 12 month visit due to tip retention.
[2]
Two deaths occurred between 30 day FU and prior to 12 month FU.
Arm/Group Title APOLLO
Hide Arm/Group Description The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Overall Number of Baseline Participants 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants
44.1  (17.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Female
49
  43.8%
Male
63
  56.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Hispanic or Latino
17
  15.2%
Not Hispanic or Latino
90
  80.4%
Unknown or Not Reported
5
   4.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
17
  15.2%
White
79
  70.5%
More than one race
0
   0.0%
Unknown or Not Reported
13
  11.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 112 participants
112
Smoking  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Never smoked or not smoked within last 10 yrs
54
  48.2%
Not a current smoker but has smoked in past 10 yrs
23
  20.5%
Current smoker, less than one pack per day
19
  17.0%
Current smoker more than or equal to one pack/day
13
  11.6%
Unknown
3
   2.7%
1.Primary Outcome
Title Number of Participants With Catheter-related Adverse Events at 30 Days
Hide Description

Premature (unintentional) catheter tip detachment with clinical sequelae

Catheter rupture/break/fracture with clinical sequelae

Retained catheter body in the vasculature

Time Frame 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Hide Outcome Measure Data
Hide Analysis Population Description
The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Arm/Group Title AVM Treatment
Hide Arm/Group Description:
Apollo™ Onyx™ Delivery Microcatheter
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days
Hide Description Rate of premature (unintentional) catheter tip detachment
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Arm/Group Title APOLLO
Hide Arm/Group Description:
The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.9%
3.Secondary Outcome
Title Number of Participants With Intentional Catheter Tip Detachment at 30 Days
Hide Description Rate of intentional catheter tip detachment
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Arm/Group Title APOLLO
Hide Arm/Group Description:
The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
68
  60.7%
4.Secondary Outcome
Title Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days
Hide Description Rate of migration of the retained catheter tip post embolization
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Arm/Group Title APOLLO
Hide Arm/Group Description:
The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days
Hide Description Rate of catheter/tip leakage from detachment zone
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Arm/Group Title APOLLO
Hide Arm/Group Description:
The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Catheter-related Adverse Events at 30 Days
Hide Description Incidence of catheter-related adverse events at 30 days
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Arm/Group Title APOLLO
Hide Arm/Group Description:
The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
31
  27.7%
7.Secondary Outcome
Title Number of Participants With Catheter-related Adverse Events at 12 Months
Hide Description Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Arm/Group Title APOLLO
Hide Arm/Group Description:
The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
68
  60.7%
8.Secondary Outcome
Title Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months
Hide Description Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Arm/Group Title APOLLO
Hide Arm/Group Description:
The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months)
Adverse Event Reporting Description

The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria:

  • All Serious Adverse Events (SAEs)
  • All device-related Adverse Events
  • All procedure-related Adverse Events
  • All AEs with an underlying neurological cause (neurological adverse event)
 
Arm/Group Title APOLLO
Hide Arm/Group Description The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
All-Cause Mortality
APOLLO
Affected / at Risk (%)
Total   3/112 (2.68%)    
Hide Serious Adverse Events
APOLLO
Affected / at Risk (%) # Events
Total   39/112 (34.82%)    
Blood and lymphatic system disorders   
Haemorrhagic anaemia  1  1/112 (0.89%)  1
Thrombocytopenia  1  1/112 (0.89%)  1
Gastrointestinal disorders   
Constipation  1  1/112 (0.89%)  1
Gastrointestinal haemorrhage  1  1/112 (0.89%)  1
Vomiting  1  1/112 (0.89%)  1
Infections and infestations   
Brain abscess  1  1/112 (0.89%)  1
Pneumonia  1  1/112 (0.89%)  1
Postoperative wound infection  1  1/112 (0.89%)  1
Urosepsis  1  1/112 (0.89%)  1
Injury, poisoning and procedural complications   
Procedural haemorrhage  1  1/112 (0.89%)  1
Subarachnoid haemorrhage  1  2/112 (1.79%)  2
Subdural haemorrhage  1  1/112 (0.89%)  1
Vascular injury  1  1/112 (0.89%)  1
Wound dehiscence  1  1/112 (0.89%)  1
Metabolism and nutrition disorders   
Electrolyte imbalance  1  1/112 (0.89%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung neoplasm malignant  1  1/112 (0.89%)  1
Nervous system disorders   
Aphasia  1  1/112 (0.89%)  1
Brain oedema  1  2/112 (1.79%)  2
Cerebral haemorrhage  1  4/112 (3.57%)  4
Cerebrospinal fluid leakage  1  1/112 (0.89%)  1
Encephalopathy  1  3/112 (2.68%)  3
Haemorrhage intracranial  1  2/112 (1.79%)  2
Haemorrhagic stroke  1  1/112 (0.89%)  1
Hemianopia  1  1/112 (0.89%)  1
Hemiparesis  1  1/112 (0.89%)  1
Hydrocephalus  1  1/112 (0.89%)  1
Intracranial pressure increased  1  1/112 (0.89%)  1
Intraventricular haemorrhage  1  1/112 (0.89%)  1
Ischaemic stroke  1  6/112 (5.36%)  6
Migraine  1  1/112 (0.89%)  1
Monoparesis  1  1/112 (0.89%)  1
Neuropathy peripheral  1  1/112 (0.89%)  1
Seizure  1  2/112 (1.79%)  2
Syncope  1  1/112 (0.89%)  1
Psychiatric disorders   
Alcohol withdrawal syndrome  1  1/112 (0.89%)  1
Hallucination  1  1/112 (0.89%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/112 (0.89%)  1
Pneumonia aspiration  1  1/112 (0.89%)  1
Pulmonary embolism  1  2/112 (1.79%)  2
Respiratory failure  1  1/112 (0.89%)  1
Respiratory tract oedema  1  1/112 (0.89%)  1
Vascular disorders   
Air embolism  1  1/112 (0.89%)  1
Deep vein thrombosis  1  2/112 (1.79%)  2
Vessel perforation  1  2/112 (1.79%)  2
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
APOLLO
Affected / at Risk (%) # Events
Total   51/112 (45.54%)    
Cardiac disorders   
Bradycardia  1  1/112 (0.89%)  1
Eye disorders   
Diplopia  1  4/112 (3.57%)  4
Photophobia  1  1/112 (0.89%)  1
Vision blurred  1  4/112 (3.57%)  4
Visual impairment  1  1/112 (0.89%)  1
Gastrointestinal disorders   
Constipation  1  1/112 (0.89%)  1
Nausea  1  1/112 (0.89%)  1
Vomiting  1  2/112 (1.79%)  2
General disorders   
Adverse drug reaction  1  1/112 (0.89%)  1
Chest Pain  1  1/112 (0.89%)  1
Fatigue  1  1/112 (0.89%)  1
Infections and infestations   
Pneumonia  1  1/112 (0.89%)  1
Urinary tract infection  1  1/112 (0.89%)  1
Injury, poisoning and procedural complications   
Pneumocephalus  1  1/112 (0.89%)  1
Pseudomeningocele  1  1/112 (0.89%)  1
Subarachnoid haemorrhage  1  2/112 (1.79%)  2
Subdural haematoma  1  1/112 (0.89%)  1
Vascular access site haematoma  1  1/112 (0.89%)  1
Vascular access site haemorrhage  1  2/112 (1.79%)  2
Metabolism and nutrition disorders   
Hypokalaemia  1  1/112 (0.89%)  1
Hypomagnesaemia  1  1/112 (0.89%)  1
Hypophosphataemia  1  1/112 (0.89%)  1
Nervous system disorders   
Brain oedema  1  2/112 (1.79%)  2
Cerebral artery thrombosis  1  1/112 (0.89%)  1
Cerebral haemorrhage  1  1/112 (0.89%)  1
Cerebral infarction  1  1/112 (0.89%)  1
Cerebral vasoconstriction  1  1/112 (0.89%)  1
Cerebrovascular accident  1  1/112 (0.89%)  1
Dizziness  1  1/112 (0.89%)  1
Dysmetria  1  1/112 (0.89%)  1
Facial paralysis  1  1/112 (0.89%)  1
Haemorrhage intracranial  1  1/112 (0.89%)  1
Headache  1  17/112 (15.18%)  18
Hemianopia homonymous  1  2/112 (1.79%)  2
Hypoaesthesia  1  1/112 (0.89%)  1
Ischaemic stroke  1  1/112 (0.89%)  1
Paraesthesia  1  2/112 (1.79%)  2
Quadrantanopia  1  1/112 (0.89%)  1
Seizure  1  8/112 (7.14%)  9
Vertebral artery dissection  1  2/112 (1.79%)  2
Renal and urinary disorders   
Haematuria  1  1/112 (0.89%)  1
Respiratory, thoracic and mediastinal disorders   
Haemoptysis  1  1/112 (0.89%)  1
Vascular disorders   
Deep vein thrombosis  1  1/112 (0.89%)  1
Hypotension  1  2/112 (1.79%)  2
Thrombophlebitis superficial  1  1/112 (0.89%)  1
Vasospasm  1  8/112 (7.14%)  11
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Darren Lacour, Sr. Manager, Clinical Project Management
Organization: Medtronic Neurovascular
Phone: 949-680-1274
EMail: darren.j.lacour@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02378883    
Other Study ID Numbers: NV-APL001
First Submitted: February 24, 2015
First Posted: March 4, 2015
Results First Submitted: March 1, 2019
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019