Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

• Sponsor: Medtronic Neurovascular Clinical Affairs (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02378883
• Collaborator: (none)
• Enrollment: 112
• Locations: 2
• Arm: 1
• Actual Duration (Months): 33.1
• Patients Per Site: 56
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.

Condition or Disease	Intervention/Treatment	Phase
Arteriovenous Malformations	Device: Apollo™ Onyx™ Delivery Micro Catheter	N/A

Detailed Description

This study is a prospective, single-arm, multicenter, post-market safety evaluation of subjects indicated for embolization of brain AVMs with the study device. The study device was developed to potentially minimize the side effects of catheter retainment and increased procedural risk associated with alternative methods necessary for removing entrapped catheters. In the event of catheter retainment, using the Apollo™ Onyx™ Delivery Microcatheter versus any a standard catheter represents leaving behind a 1.5 - 3.0 cm long detachable tip in the Onyx™ Onyx™ Delivery Microcatheter cast versus an average 165 cm long catheter in the vasculature.

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
• Actual Study Start Date: May 18, 2015
• Actual Primary Completion Date: Feb 20, 2018
• Actual Study Completion Date: Feb 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: AVM treatment Apollo™ Onyx™ Delivery Micro Catheter	Device: Apollo™ Onyx™ Delivery Micro Catheter

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Catheter-related Adverse Events at 30 Days [30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter]

   Premature (unintentional) catheter tip detachment with clinical sequelae Catheter rupture/break/fracture with clinical sequelae Retained catheter body in the vasculature

Secondary Outcome Measures

1. Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days [30 days]

   Rate of premature (unintentional) catheter tip detachment

2. Number of Participants With Intentional Catheter Tip Detachment at 30 Days [30 days]

   Rate of intentional catheter tip detachment

3. Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days [30 days]

   Rate of migration of the retained catheter tip post embolization

4. Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days [30 days]

   Rate of catheter/tip leakage from detachment zone

5. Number of Participants With Catheter-related Adverse Events at 30 Days [30 days]

   Incidence of catheter-related adverse events at 30 days

6. Number of Participants With Catheter-related Adverse Events at 12 Months [12 months]

   Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)

7. Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months [12 months]

   Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The Subject or Subject's legally authorized representative has signed and dated an informed consent form.

• The Subject has a confirmed diagnosis of a brain AVM.

• The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.

• The Subject has a life expectancy of at least 1 year.

• The Subject agrees to and is capable of completing all study-required procedures.

Exclusion Criteria:

• Current participation in another investigational drug or device study that evaluates treatments for brain AVMs or other cerebrovascular disease.

• The Subject has a bleeding disorder.

• The Subject is not a candidate for the use of vasodilators.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiology Imaging Associates, P.C.	Englewood	Colorado	United States	80112
2	Brigham's & Women Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Medtronic Neurovascular Clinical Affairs

Investigators

• Principal Investigator: Mohammed A Aziz-Sultan, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 5, 2014

More Information

Publications

None provided.

• Responsible Party: Medtronic Neurovascular Clinical Affairs
• ClinicalTrials.gov Identifier: NCT02378883
• Other Study ID Numbers: NV-APL001
• First Posted: Mar 4, 2015
• Last Update Posted: Apr 29, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Medtronic Neurovascular Clinical Affairs: Apollo; Onyx; Arteriovenous malformation; AVM; Onyx™ Liquid Embolic System; Apollo™ Onyx™ Delivery Microcatheter; Brain Diseases
• Additional relevant MeSH terms: Arteriovenous Malformations; Congenital Abnormalities

Study Results

Participant Flow

Arm/Group Title	APOLLO
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
COMPLETED	112
NOT COMPLETED	9
Period Title: Enrollment
STARTED	112
COMPLETED	112
NOT COMPLETED	0
Period Title: Enrollment
STARTED	112
COMPLETED	106
NOT COMPLETED	6
Period Title: Enrollment
STARTED	46
COMPLETED	41
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	APOLLO
Arm/Group Description	The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Overall Participants	112
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.1 (17.6)
Sex: Female, Male (Count of Participants)
Female	49 43.8%
Male	63 56.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	17 15.2%
Not Hispanic or Latino	90 80.4%
Unknown or Not Reported	5 4.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 2.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	17 15.2%
White	79 70.5%
More than one race	0 0%
Unknown or Not Reported	13 11.6%
Region of Enrollment (participants) [Number]
United States	112 100%
Smoking (Count of 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%
Current smoker more than or equal to one pack/day	13 11.6%
Unknown	3 2.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Catheter-related Adverse Events at 30 Days
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

Outcome Measure Data

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
Arm/Group Description	Apollo™ Onyx™ Delivery Microcatheter
Measure Participants	112
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days
Description	Rate of premature (unintentional) catheter tip detachment
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Arm/Group Title	APOLLO
Arm/Group Description	The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Measure Participants	112
Count of Participants [Participants]	1 0.9%

3. Secondary Outcome

Title	Number of Participants With Intentional Catheter Tip Detachment at 30 Days
Description	Rate of intentional catheter tip detachment
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Arm/Group Title	APOLLO
Arm/Group Description	The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Measure Participants	112
Count of Participants [Participants]	68 60.7%

4. Secondary Outcome

Title	Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days
Description	Rate of migration of the retained catheter tip post embolization
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Arm/Group Title	APOLLO
Arm/Group Description	The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Measure Participants	112
Count of Participants [Participants]	0 0%

5. Secondary Outcome

Title	Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days
Description	Rate of catheter/tip leakage from detachment zone
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Arm/Group Title	APOLLO
Arm/Group Description	The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Measure Participants	112
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	Number of Participants With Catheter-related Adverse Events at 30 Days
Description	Incidence of catheter-related adverse events at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Arm/Group Title	APOLLO
Arm/Group Description	The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Measure Participants	112
Count of Participants [Participants]	31 27.7%

7. Secondary Outcome

Title	Number of Participants With Catheter-related Adverse Events at 12 Months
Description	Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Arm/Group Title	APOLLO
Arm/Group Description	The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Measure Participants	112
Count of Participants [Participants]	68 60.7%

8. Secondary Outcome

Title	Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months
Description	Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Arm/Group Title	APOLLO
Arm/Group Description	The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Measure Participants	112
Count of Participants [Participants]	0 0%

Adverse Events

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
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 (%)	# Events
Total	3/112 (2.7%)
Serious Adverse Events
	APOLLO
	Affected / at Risk (%)	# Events
Total	39/112 (34.8%)
Blood and lymphatic system disorders
Haemorrhagic anaemia	1/112 (0.9%)	1
Thrombocytopenia	1/112 (0.9%)	1
Gastrointestinal disorders
Constipation	1/112 (0.9%)	1
Gastrointestinal haemorrhage	1/112 (0.9%)	1
Vomiting	1/112 (0.9%)	1
Infections and infestations
Brain abscess	1/112 (0.9%)	1
Pneumonia	1/112 (0.9%)	1
Postoperative wound infection	1/112 (0.9%)	1
Urosepsis	1/112 (0.9%)	1
Injury, poisoning and procedural complications
Procedural haemorrhage	1/112 (0.9%)	1
Subarachnoid haemorrhage	2/112 (1.8%)	2
Subdural haemorrhage	1/112 (0.9%)	1
Vascular injury	1/112 (0.9%)	1
Wound dehiscence	1/112 (0.9%)	1
Metabolism and nutrition disorders
Electrolyte imbalance	1/112 (0.9%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	1/112 (0.9%)	1
Nervous system disorders
Aphasia	1/112 (0.9%)	1
Brain oedema	2/112 (1.8%)	2
Cerebral haemorrhage	4/112 (3.6%)	4
Cerebrospinal fluid leakage	1/112 (0.9%)	1
Encephalopathy	3/112 (2.7%)	3
Haemorrhage intracranial	2/112 (1.8%)	2
Haemorrhagic stroke	1/112 (0.9%)	1
Hemianopia	1/112 (0.9%)	1
Hemiparesis	1/112 (0.9%)	1
Hydrocephalus	1/112 (0.9%)	1
Intracranial pressure increased	1/112 (0.9%)	1
Intraventricular haemorrhage	1/112 (0.9%)	1
Ischaemic stroke	6/112 (5.4%)	6
Migraine	1/112 (0.9%)	1
Monoparesis	1/112 (0.9%)	1
Neuropathy peripheral	1/112 (0.9%)	1
Seizure	2/112 (1.8%)	2
Syncope	1/112 (0.9%)	1
Psychiatric disorders
Alcohol withdrawal syndrome	1/112 (0.9%)	1
Hallucination	1/112 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/112 (0.9%)	1
Pneumonia aspiration	1/112 (0.9%)	1
Pulmonary embolism	2/112 (1.8%)	2
Respiratory failure	1/112 (0.9%)	1
Respiratory tract oedema	1/112 (0.9%)	1
Vascular disorders
Air embolism	1/112 (0.9%)	1
Deep vein thrombosis	2/112 (1.8%)	2
Vessel perforation	2/112 (1.8%)	2
Other (Not Including Serious) Adverse Events
	APOLLO
	Affected / at Risk (%)	# Events
Total	51/112 (45.5%)
Cardiac disorders
Bradycardia	1/112 (0.9%)	1
Eye disorders
Diplopia	4/112 (3.6%)	4
Photophobia	1/112 (0.9%)	1
Vision blurred	4/112 (3.6%)	4
Visual impairment	1/112 (0.9%)	1
Gastrointestinal disorders
Constipation	1/112 (0.9%)	1
Nausea	1/112 (0.9%)	1
Vomiting	2/112 (1.8%)	2
General disorders
Adverse drug reaction	1/112 (0.9%)	1
Chest Pain	1/112 (0.9%)	1
Fatigue	1/112 (0.9%)	1
Infections and infestations
Pneumonia	1/112 (0.9%)	1
Urinary tract infection	1/112 (0.9%)	1
Injury, poisoning and procedural complications
Pneumocephalus	1/112 (0.9%)	1
Pseudomeningocele	1/112 (0.9%)	1
Subarachnoid haemorrhage	2/112 (1.8%)	2
Subdural haematoma	1/112 (0.9%)	1
Vascular access site haematoma	1/112 (0.9%)	1
Vascular access site haemorrhage	2/112 (1.8%)	2
Metabolism and nutrition disorders
Hypokalaemia	1/112 (0.9%)	1
Hypomagnesaemia	1/112 (0.9%)	1
Hypophosphataemia	1/112 (0.9%)	1
Nervous system disorders
Brain oedema	2/112 (1.8%)	2
Cerebral artery thrombosis	1/112 (0.9%)	1
Cerebral haemorrhage	1/112 (0.9%)	1
Cerebral infarction	1/112 (0.9%)	1
Cerebral vasoconstriction	1/112 (0.9%)	1
Cerebrovascular accident	1/112 (0.9%)	1
Dizziness	1/112 (0.9%)	1
Dysmetria	1/112 (0.9%)	1
Facial paralysis	1/112 (0.9%)	1
Haemorrhage intracranial	1/112 (0.9%)	1
Headache	17/112 (15.2%)	18
Hemianopia homonymous	2/112 (1.8%)	2
Hypoaesthesia	1/112 (0.9%)	1
Ischaemic stroke	1/112 (0.9%)	1
Paraesthesia	2/112 (1.8%)	2
Quadrantanopia	1/112 (0.9%)	1
Seizure	8/112 (7.1%)	9
Vertebral artery dissection	2/112 (1.8%)	2
Renal and urinary disorders
Haematuria	1/112 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Haemoptysis	1/112 (0.9%)	1
Vascular disorders
Deep vein thrombosis	1/112 (0.9%)	1
Hypotension	2/112 (1.8%)	2
Thrombophlebitis superficial	1/112 (0.9%)	1
Vasospasm	8/112 (7.1%)	11

Limitations/Caveats

Study was completed.

More Information

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.