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The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISEâ„¢ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.
The data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CORDIS ENTERPRISEâ„¢ VRD during the index procedure. While only limited inclusion or exclusion criteria are specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up up to 6 months. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the VRD placement, coiling procedure, application of antiplatelet medication and any other medical therapy to be provided according to local usual practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Endovascular | All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Reconstruction Device | Device | CORDIS ENTERPRISEâ„¢ VRD |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE) | 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 | Intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device or Procedure Related Adverse Events (AEs) | Incidence of device or procedure related adverse events during the index procedure and till discharge | index procedure to discharge; an average of 3.8 days |
| Satisfactory Coil Mass Position |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering of an intracranial aneurysm and necessitating an endovascular treatment.
Patients who meet all of the general inclusion criteria and none of the exclusion criteria and who agree to voluntarily sign a informed consent form will be enrolled into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Bendszus Martin, MD | Wuerzburg University Hospital | Principal Investigator |
| Boris Lubicz, MD | Université Libre de Bruxelles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université Libre de Bruxelles | Brussels | 1070 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Endovascular | All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device (VRD). Vascular Reconstruction Device: CORDIS ENTERPRISEâ„¢ VRD |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Endovascular | All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device and were consented before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISEâ„¢ VRD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE) | 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 | Posted | Number | 95% Confidence Interval | participants | Intra-procedure |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Endovascular | All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISEâ„¢ VRD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischemic Stroke | Nervous system disorders | Ischemic Stroke in a different territory than the stented one |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stent thrombosis | Injury, poisoning and procedural complications |
This study was powered to have a total of 250 subjects, but was stopped early due to slow enrollment. Hence, this study ended up having only 105 total subjects, making it underpowered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arnaud Nicolas | Codman&Shurtleff | +33 0 155 004 543 | anicolas@its.jnj.com |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
| 6 months |
| Aneurysm Occlusion | Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm) | post procedure to 6 months |
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Medical History | Number | Participants |
|
| Neurological History | Number | Participants |
|
| Previous Neurological Surgical Procedures | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Device or Procedure Related Adverse Events (AEs) | Incidence of device or procedure related adverse events during the index procedure and till discharge | Posted | Number | participants | index procedure to discharge; an average of 3.8 days |
|
|
|
| Secondary | Satisfactory Coil Mass Position | Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically | 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 | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Aneurysm Occlusion | Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm) | 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 | Posted | Number | participants | post procedure to 6 months |
|
|
|
| 5 |
| 105 |
| 21 |
| 105 |
| retroperitoneal hematoma | Injury, poisoning and procedural complications | retroperitoneal hematoma requiring additional hospitalization |
|
| Thrombophlebitis | Vascular disorders | Left superior limb thrombophlebitis and atrial fibrillation Headache and right hemiparesis |
|
| stent thrombosis | Injury, poisoning and procedural complications | Incomplete stent thrombosis started after stent and first coil placement. |
|
| Cancer | Respiratory, thoracic and mediastinal disorders | Lung metastasis |
|
| embolization/ re-embolization of non-study aneurysm | Nervous system disorders |
|
| coil protrusion | Injury, poisoning and procedural complications | In four subjects coil protrusion occurred before placement of the Enterprise stent and was hence not related to the device. In the remaining subject the timing of coil protrusion (before/after stent placement) was not specified by the investigator. |
|
| stent migration | Injury, poisoning and procedural complications |
|
| cholangitis with septicemia | Hepatobiliary disorders | moderate sclerosing cholangitis post cholecystectomy and septicemia |
|
| stretched/unravelled coil | Injury, poisoning and procedural complications |
|
| perforator infarction | Nervous system disorders |
|
| subdural hematoma | Nervous system disorders |
|
| visual disturbances with cintilating scotoma | Nervous system disorders |
|
| Phasic Disorders | Musculoskeletal and connective tissue disorders |
|
| temporo-spatial disorientation | Nervous system disorders |
|
| Epistaxis | Injury, poisoning and procedural complications |
|
| Headache | Nervous system disorders |
|
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Residual Aneurysm (Raymond 3) |
|