Trial · NCT00486226
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
NCT00486226, Completed, Codman & Shurtleff; results first posted 2014-04-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System. Trials, record NCT00486226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00486226
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
- NCT number
- NCT00486226
- Status
- Completed
- Enrollment
- 105 participants, actual
- Lead sponsor
- Codman & Shurtleff
- Conditions
- Intracranial Aneurysm
- Interventions
- Vascular Reconstruction Device
- First posted
- 2007-06-14
- Last updated
- 2018-12-12
- Results first posted
- 2014-04-21
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Intra-procedure | 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 |
| Secondary | Device or Procedure Related Adverse Events (AEs) | 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 |
| Secondary | Satisfactory Coil Mass Position | 6 months | Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically |
| Secondary | Aneurysm Occlusion | post procedure to 6 months | Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Intra-procedure | participants | NUMBER | |
| SECONDARY | Device or Procedure Related Adverse Events (AEs) | index procedure to discharge; an average of 3.8 days | participants | NUMBER | |
| SECONDARY | Satisfactory Coil Mass Position | 6 months | 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 | participants | NUMBER |
| SECONDARY | Aneurysm Occlusion | post procedure to 6 months | 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 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE) | 1 Endovascular | 64 | 95% Confidence Interval 51.6 to 70.0 | participants | |
| Device or Procedure Related Adverse Events (AEs) | 1 Endovascular | 14 | participants | ||
| Satisfactory Coil Mass Position | 1 Endovascular | 60 | participants | ||
| Aneurysm Occlusion | Endovascular - Occlusion Results Immediately Post-procedure | Complete Occlusion (Raymond 1) | 17 | participants | |
| Aneurysm Occlusion | Endovascular - Occlusion Results at 6 Months Follow-up | Complete Occlusion (Raymond 1) | 46 | participants | |
| Aneurysm Occlusion | Endovascular - Occlusion Results Immediately Post-procedure | Neck Remnant (Raymond 2) | 19 | participants | |
| Aneurysm Occlusion | Endovascular - Occlusion Results at 6 Months Follow-up | Neck Remnant (Raymond 2) | 8 | participants | |
| Aneurysm Occlusion | Endovascular - Occlusion Results Immediately Post-procedure | Residual Aneurysm (Raymond 3) | 48 | participants | |
| Aneurysm Occlusion | Endovascular - Occlusion Results at 6 Months Follow-up | Residual Aneurysm (Raymond 3) | 25 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1 Endovascular | 105 | |
| Overall Study | COMPLETED | 1 Endovascular | 92 | |
| Overall Study | NOT COMPLETED | 1 Endovascular | 13 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | stent thrombosis | Injury, poisoning and procedural complications | 1 Endovascular | 2 | 105 | 2 |
| other | embolization/ re-embolization of non-study aneurysm | Nervous system disorders | 1 Endovascular | 5 | 105 | 7 |
| other | coil protrusion | Injury, poisoning and procedural complications | 1 Endovascular | 5 | 105 | 5 |
| other | stent migration | Injury, poisoning and procedural complications | 1 Endovascular | 2 | 105 | 2 |
| other | cholangitis with septicemia | Hepatobiliary disorders | 1 Endovascular | 1 | 105 | 1 |
| other | stretched/unravelled coil | Injury, poisoning and procedural complications | 1 Endovascular | 2 | 105 | 2 |
| other | perforator infarction | Nervous system disorders | 1 Endovascular | 1 | 105 | 1 |
| other | subdural hematoma | Nervous system disorders | 1 Endovascular | 1 | 105 | 1 |
| other | visual disturbances with cintilating scotoma | Nervous system disorders | 1 Endovascular | 1 | 105 | 1 |
| other | Phasic Disorders | Musculoskeletal and connective tissue disorders | 1 Endovascular | 1 | 105 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 Endovascular | ||
| Total, other adverse events | 1 Endovascular | 21 | 105 |
| Total, serious adverse events | 1 Endovascular | 5 | 105 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00486226
GET https://conductscience.org/api/trials/v1/NCT00486226/registered