N/A
Completed N=105
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
Source: ClinicalTrials.gov NCT00486226 ↗Enrolled (actual)
105
Serious AEs
4.8%
Results posted
Apr 2014
Primary outcomePrimary: 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
Summary
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
64 | — |
| SECONDARY Device or Procedure Related Adverse Events (AEs) |
14 | — |
| SECONDARY Satisfactory Coil Mass Position |
60 | — |
| SECONDARY Aneurysm Occlusion |
17; 46; 19; 8; 48; 25 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must be >= 18 years of age and less than 80 years.
- Diagnosis of a ruptured (Hunt and Hess Grade I - III) or unruptured intracranial aneurysm at the time of the treatment
- Subject (or his/her legal representative) provides written informed consent for the use of his/her peri-procedural and follow-up data
Exclusion Criteria
- Diagnosis of Hunt and Hess Grade IV or V subarachnoid hemorrhage at the time of the treatment
- Severe co-morbidity associated with a life-expectancy of less than six months
- Poor neurological status at baseline
- Known allergies to Nitinol metal
- Known allergies to aspirin, heparin, ticlopidine, or clopidogrel or unable or unwilling to tolerate therapy
- Participation in an investigational drug or another device study is only allowed after written approval of the coordinating investigator or Cordis Medical Monitor.
- Implantation of an intracranial stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
- Implantation of carotid stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
- Atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
Data sourced from ClinicalTrials.gov (NCT00486226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.