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

NCT00486226 | Completed Results DMC

• 1 other identifier: EN07-01
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Device or Procedure Related Adverse Events (AEs)

  index procedure to discharge; an average of 3.8 days

• Satisfactory Coil Mass Position

  6 months

• Aneurysm Occlusion

  post procedure to 6 months

Study Arms (1)

1 Endovascular

All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.

Device: Vascular Reconstruction Device

Interventions

Vascular Reconstruction Device DEVICE

CORDIS ENTERPRISE™ VRD

Also known as: ENTERPRISE, Codman ENTERPRISE, Codman VRD

1 Endovascular

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Codman & Shurtleff: lead

Study Sites (1)

Université Libre de Bruxelles

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

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.

Results Point of Contact

• Title: Arnaud Nicolas
• Organization: Codman&Shurtleff

anicolas@its.jnj.com

+33 0 155 004 543

Study Officials

• Bendszus Martin, MD

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

• Boris Lubicz, MD

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 14, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: December 12, 2018
• Results First Posted: April 21, 2014

Record last verified: 2018-12

Locations

BE (1)