Trial Outcomes & Findings for Coil Assisted Flow Diversion Safety and Performance Study (NCT NCT04187573)
NCT ID: NCT04187573
Last Updated: 2024-11-20
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
From day 31 to 6 months after treatment
Results posted on
2024-11-20
Participant Flow
Participant milestones
| Measure |
Intervention/Neqstent
Device: Neqstent Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Coil Assisted Flow Diversion Safety and Performance Study
Baseline characteristics by cohort
| Measure |
Intervention/Neqstent
n=38 Participants
Device: Neqstent Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From day 31 to 6 months after treatmentPopulation: Intent-to-treat: All eligible subjects who underwent an attempt with the Neqstent device
Outcome measures
| Measure |
Intervention/Neqstent
n=37 Participants
Device: Neqstent Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
|
|---|---|
|
The Proportion of Subjects With Death of Any Non-accidental Cause or Any Major Disabling Stroke After Treatment or Major Disabling Stroke or Death Due to Neurological Cause.
|
2 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent-to-treat: All eligible subjects who underwent an attempt with the Neqstent device.
Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.
Outcome measures
| Measure |
Intervention/Neqstent
n=32 Participants
Device: Neqstent Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
|
|---|---|
|
The Proportion of Subjects With Complete Occlusion
|
26 Participants
|
Adverse Events
Intervention/Neqstent
Serious events: 15 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intervention/Neqstent
n=37 participants at risk
Device: Neqstent Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
|
|---|---|
|
Nervous system disorders
Aneurysm Reccurence
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Stroke
|
18.9%
7/37 • Number of events 9 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Headache
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Injury, poisoning and procedural complications
Shoulder Injury
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Distal Embolic Phenomenon
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Hemorrhagic Stroke
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Investigations
Device Movement
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Seizure
|
2.7%
1/37 • Number of events 2 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Injury, poisoning and procedural complications
Target Aneurysm Rupture
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Injury
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Vascular disorders
Vasculitis
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Vascular disorders
Access Site - Hematoma
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Non-index Aneurysm Treatment
|
5.4%
2/37 • Number of events 2 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Psychiatric disorders
Suicide Attempt
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
Other adverse events
| Measure |
Intervention/Neqstent
n=37 participants at risk
Device: Neqstent Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
|
|---|---|
|
Vascular disorders
Access Site - Hematoma
|
10.8%
4/37 • Number of events 4 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Headache and Nosebleed
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Headache
|
10.8%
4/37 • Number of events 4 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Stroke
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
General disorders
Disorientation with trouble speaking
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Tinnitus
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Surgical and medical procedures
Dental Surgery
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Skin and subcutaneous tissue disorders
Radiation induced epilation
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
General disorders
Vomiting
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Injury, poisoning and procedural complications
Femoral Artery Dissection
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Cardiac disorders
Chest Pain
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Numbness
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Cardiac disorders
Vasovagal Episode
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Nervous system disorders
Dysaesthesia
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Injury, poisoning and procedural complications
Fractured Fibula
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Abcess
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
General disorders
Bleeding Event (Non-neurological)
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
|
General disorders
Dizziness/Fall
|
2.7%
1/37 • Number of events 1 • 2 years
Per protocol, the SAE definition includes adverse events where medical or surgical intervention was necessitated to prevent life-threatening illness. Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered to be an SAE.
|
Additional Information
Vanessa Sarge
Cerus Endovascular, part of Stryker Corporation
Phone: 5103292048
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place