Trial Outcomes & Findings for Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE) (NCT NCT03873714)

NCT ID: NCT03873714

Last Updated: 2025-06-19

Results Overview

Incidence of major stroke in the territory supplied by the treated artery or neurological death.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 1 year post-procedure
• Results posted on: 2025-06-19

Participant Flow

The study was placed on an enrollment hold on 14 June 2020.

A total of 14 subjects were enrolled, of which seven (7) subjects were treated, six (6) subjects were withdrawn, and one (1) subject was a Screen Failure.

Participant milestones

Measure	Study Group Pipeline™ Vantage Embolization Device with Shield Technology™
Overall Study STARTED	14
Overall Study Primary Outcome Completion	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Study Group Pipeline™ Vantage Embolization Device with Shield Technology™
Overall Study Six (6) were withdrawn, and one (1) was a Screen Failure	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Study Group n=7 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Age, Continuous	58.1 years STANDARD_DEVIATION 14.57 • n=7 Participants
Sex: Female, Male Female	7 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=7 Participants
Region of Enrollment United States	7 participants n=7 Participants

PRIMARY outcome

Timeframe: 1 year post-procedure

Population: All consented subjects in whom deployment of the Pipeline™ Vantage device was attempted

Incidence of major stroke in the territory supplied by the treated artery or neurological death.

Outcome measures

Measure	Study Group n=7 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Safety: Incidence of Major Stroke or Neurological Death	1 Participants

PRIMARY outcome

Timeframe: 1 year post-procedure

Population: All consented subjects in whom deployment of the Pipeline™ Vantage device was attempted. Population data is inadequate for a complete primary effectiveness endpoint evaluation.

Incidence of complete aneurysm occlusion (Raymond Roy Scale Class 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm at 1-year post-procedure.

Outcome measures

Measure	Study Group n=7 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Effectiveness: Incidence of Complete Aneurysm Occlusion	6 Participants

SECONDARY outcome

Timeframe: Day 0

Population: All Pipeline™ Vantage devices with deployment attempted

Incidence of successful device implantation at the target site

Outcome measures

Measure	Study Group n=10 Devices Pipeline™ Vantage Embolization Device with Shield Technology™
Effectiveness: Incidence of Successful Device Implantation	9 Devices

SECONDARY outcome

Timeframe: 1 year post-procedure

Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™

Incidence of complete aneurysm occlusion (Raymond Roy Class 1)

Outcome measures

Measure	Study Group n=7 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Effectiveness: Incidence of Complete Aneurysm Occlusion	6 Participants

SECONDARY outcome

Timeframe: 1 year post-procedure

Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™

Incidence of target aneurysm recurrence at 1 year post-procedure

Outcome measures

Measure	Study Group n=7 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Effectiveness: Incidence of Target Aneurysm Recurrence	0 Participants

SECONDARY outcome

Timeframe: 2 and 3 years post-procedure

Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™

Incidence of major stroke in the territory supplied by the treated artery or neurological death

Outcome measures

Measure	Study Group n=7 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Safety: Incidence of Major Stroke	0 Participants

SECONDARY outcome

Timeframe: 30 days post-procedure

Population: All consented subjects in whom deployment of the Pipeline™ Vantage device was attempted.

Incidence of major stroke in the territory supplied by the treated artery or neurological death

Outcome measures

Measure	Study Group n=7 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Safety: Incidence of Major Stroke	1 Participants

SECONDARY outcome

Timeframe: >30 days post-procedure through 1 year post-procedure

Population: All consented subjects in whom deployment of the Pipeline™ Vantage device was attempted.

Incidence of delayed intraparenchymal hemorrhage >30 days post-procedure through 1-year post-procedure

Outcome measures

Measure	Study Group n=7 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Safety: Incidence of Delayed Intraparenchymal Hemorrhage	0 Participants

SECONDARY outcome

Timeframe: Assessed from procedure through 3 years post-procedure

Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™

Incidence of subjects with disabling strokes that have a mRS decline to a score of 3 or more (mRS ≥ 3) due to a stroke-related cause assessed at a minimum of 90 days post-stroke event

Outcome measures

Measure	Study Group n=7 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Safety: Incidence of Subjects With Disabling Strokes	1 Participants

SECONDARY outcome

Timeframe: 3 years post-procedure

Population: Subject that did not have complete occlusion at 1 year.

Incidence of complete aneurysm occlusion (Raymond Roy Class 1)

Outcome measures

Measure	Study Group n=1 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Effectiveness: Incidence of Complete Aneurysm Occlusion	0 Participants

SECONDARY outcome

Timeframe: 3 years post-procedure

Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™

Incidence of target aneurysm recurrence 3-years post-procedure

Outcome measures

Measure	Study Group n=6 Participants Pipeline™ Vantage Embolization Device with Shield Technology™
Effectiveness: Incidence of Target Aneurysm Recurrence	0 Participants

Adverse Events

Study Group

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Study Group n=7 participants at risk Pipeline™ Vantage Embolization Device with Shield Technology™
Nervous system disorders Cerebral Hematoma	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Nervous system disorders Cerebrovascular Accident	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Nervous system disorders Encephalopathy	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Surgical and medical procedures Cerebral Endovascular Aneurysm Repair	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.

Other adverse events

Measure	Study Group n=7 participants at risk Pipeline™ Vantage Embolization Device with Shield Technology™
Blood and lymphatic system disorders Normocytic Anemia	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Cardiac disorders Bradycardia	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Gastrointestinal disorders Hemorrhoids	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
General disorders Asthenia	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
General disorders Chest Pain	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
General disorders Vascular Stent Stenosis	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Infections and infestations Kidney Infection	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Infections and infestations Urinary Tract Infection	28.6% 2/7 • Number of events 2 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Injury, poisoning and procedural complications Vascular Access Site Discharge	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Injury, poisoning and procedural complications Vascular Access Site Hematoma	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Musculoskeletal and connective tissue disorders Muscle Spasms	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Nervous system disorders Paraesthesia	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Reproductive system and breast disorders Menorrhagia	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Reproductive system and breast disorders Vaginal Hemorrhage	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Aspiration	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Nervous system disorders Cerebral Artery Stenosis	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Vascular disorders Hematoma	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Vascular disorders Hypotension	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Vascular disorders Vasospasm	28.6% 2/7 • Number of events 4 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • Number of events 1 • Adverse event data were collected for each subject from the time of consent through 3 years post-procedure. Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. (ISO 14155:2011 3.2). MedDRA preferred term used for site reporting of adverse events.

Additional Information

Director, Global Clinical Research

Medtronic Neurovascular

Phone: 949.837.3700

Email: rs.advance@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place