Trial Outcomes & Findings for The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System (NCT NCT00486226)

Last Updated: 2018-12-12

Results Overview

Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency. Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically

Recruitment status

COMPLETED

Target enrollment

105 participants

Primary outcome timeframe

Intra-procedure

Results posted on

2018-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	1 Endovascular All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device (VRD). Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
Overall Study STARTED	105
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	1 Endovascular All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device (VRD). Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
Overall Study Death	3
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	8

Baseline Characteristics

The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Endovascular n=105 Participants All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device and were consented before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
Age, Continuous	55.3 years STANDARD_DEVIATION 12.6 • n=93 Participants
Sex: Female, Male Female	75 Participants n=93 Participants
Sex: Female, Male Male	30 Participants n=93 Participants
Medical History Cardiovascular Disease	4 Participants n=93 Participants
Medical History Chronic Pulmonary Disease	1 Participants n=93 Participants
Medical History Immunologic	1 Participants n=93 Participants
Medical History Endocrice/Metabolic Disease	1 Participants n=93 Participants
Medical History Diabetes	2 Participants n=93 Participants
Medical History Renal Disease	2 Participants n=93 Participants
Medical History Cancer	6 Participants n=93 Participants
Medical History Dyslipidemia/Hypercolesterolemia	4 Participants n=93 Participants
Medical History Vasculitis	1 Participants n=93 Participants
Medical History Obesity	1 Participants n=93 Participants
Medical History Smoking	1 Participants n=93 Participants
Medical History Other	4 Participants n=93 Participants
Medical History Hypertension	38 Participants n=93 Participants
Neurological History Recurrent Headache	18 Participants n=93 Participants
Neurological History Epilepsy	3 Participants n=93 Participants
Neurological History Cranial Nerve Palsy/ Paresis	2 Participants n=93 Participants
Neurological History TIA/CVA	21 Participants n=93 Participants
Previous Neurological Surgical Procedures	36 Participants n=93 Participants

PRIMARY outcome

Timeframe: Intra-procedure

Outcome measures

Outcome measures
Measure	1 Endovascular n=105 Participants All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD	Endovascular - Occlusion Results at 6 Months Follow-up Aneurysm occlusion assessed at 6 months follow-up using the Raymond Scale.
The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)	64 participants Interval 51.6 to 70.0	—

SECONDARY outcome

Timeframe: index procedure to discharge; an average of 3.8 days

Incidence of device or procedure related adverse events during the index procedure and till discharge

Outcome measures

Outcome measures
Measure	1 Endovascular n=105 Participants All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD	Endovascular - Occlusion Results at 6 Months Follow-up Aneurysm occlusion assessed at 6 months follow-up using the Raymond Scale.
Device or Procedure Related Adverse Events (AEs)	14 participants	—

SECONDARY outcome

Timeframe: 6 months

Population: no data was available for 33 subjects; either because the investigator didn't submit the images or due to poor quality of the submitted images

Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically

Outcome measures

Outcome measures
Measure	1 Endovascular n=72 Participants All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD	Endovascular - Occlusion Results at 6 Months Follow-up Aneurysm occlusion assessed at 6 months follow-up using the Raymond Scale.
Satisfactory Coil Mass Position	60 participants	—

SECONDARY outcome

Timeframe: post procedure to 6 months

Population: no data was available for 21 subjects post-procedure and 26 subjects at 6 months follow-up; either because the investigator didn't submit the images or due to poor quality of the submitted images

Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)

Outcome measures

Outcome measures
Measure	1 Endovascular n=84 Participants All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD	Endovascular - Occlusion Results at 6 Months Follow-up n=79 Participants Aneurysm occlusion assessed at 6 months follow-up using the Raymond Scale.
Aneurysm Occlusion Complete Occlusion (Raymond 1)	17 participants	46 participants
Aneurysm Occlusion Neck Remnant (Raymond 2)	19 participants	8 participants
Aneurysm Occlusion Residual Aneurysm (Raymond 3)	48 participants	25 participants

Adverse Events

1 Endovascular

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1 Endovascular n=105 participants at risk All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
Nervous system disorders Ischemic Stroke	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Injury, poisoning and procedural complications retroperitoneal hematoma	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Vascular disorders Thrombophlebitis	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Injury, poisoning and procedural complications stent thrombosis	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Respiratory, thoracic and mediastinal disorders Cancer	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.

Other adverse events

Other adverse events
Measure	1 Endovascular n=105 participants at risk All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD
Injury, poisoning and procedural complications stent thrombosis	1.9% 2/105 • Number of events 2 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Nervous system disorders embolization/ re-embolization of non-study aneurysm	4.8% 5/105 • Number of events 7 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Injury, poisoning and procedural complications coil protrusion	4.8% 5/105 • Number of events 5 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Injury, poisoning and procedural complications stent migration	1.9% 2/105 • Number of events 2 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Hepatobiliary disorders cholangitis with septicemia	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Injury, poisoning and procedural complications stretched/unravelled coil	1.9% 2/105 • Number of events 2 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Nervous system disorders perforator infarction	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Nervous system disorders subdural hematoma	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Nervous system disorders visual disturbances with cintilating scotoma	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Musculoskeletal and connective tissue disorders Phasic Disorders	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Nervous system disorders temporo-spatial disorientation	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Injury, poisoning and procedural complications Epistaxis	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.
Nervous system disorders Headache	0.95% 1/105 • Number of events 1 • procedure until 6 months follow-up At each evaluation of a subject enrolled in the registry (procedure, discharge, 6 months follow-up) the investigator determined whether any adverse events had occurred.

Additional Information

Arnaud Nicolas

Codman&Shurtleff

Phone: +33 0 155 004 543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place