TRUfill®'s Line in Intracranial aNeurysm Embolisation (TRULINE)
This study is currently recruiting participants.
Verified February 2013 by Codman & Shurtleff
Sponsor:
Codman & Shurtleff
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT01503775
First received: December 23, 2011
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
The objective of this study is to evaluate the long term efficacy and safety of the CODMAN TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or non-ruptured aneurysms in real-life routine clinical practice.
| Condition |
|---|
|
Aneurysms |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective, Multicentric Observational Study Evaluating the Long Term Efficacy and Safety of the CODMAN TRUFILL®'s Line of Coils in the Endovascular Treatment of Intracranial Aneurysms |
Resource links provided by NLM:
Further study details as provided by Codman & Shurtleff:
Primary Outcome Measures:
- The long term safety of the coiling procedure with the CODMAN TRUFILL®'s line of coils will be assessed by the combined morbidity-mortality rate (CMMR) observed during the procedure and up to 1 year post-procedure follow-up. [ Time Frame: Observed during the procedure and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The procedural CMMR observed during the procedure and up to 30 Days post procedure follow-up. [ Time Frame: Observed during the procedure and up to 30 Days post procedure follow-up. ] [ Designated as safety issue: Yes ]
- The rate of permanent morbidity and mortality observed at 30 Days and at 1 year post-procedure follow-up, defined as a mRS of 3 to 6. [ Time Frame: Observed at 30 Days and at 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
- The rate of absence of deterioration or improvement of the neurological status observed at 30 days and at 1 year post procedure follow-up [ Time Frame: Observed at 30 days and at 1 year post procedure follow-up ] [ Designated as safety issue: Yes ]
- The overall rate of Adverse Event/Serious Adverse Event observed during the procedure, at 30 days and up to 1 year post-procedure follow-up [ Time Frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
- The rate of Adverse Event/Serious Adverse Event related to the device and/or to the procedure observed during the procedure, at 30 days and up to 1 year post-procedure follow-up [ Time Frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
- The rate of Unanticipated Adverse Device Effects observed during the procedure, at 30 days and up to 1 year post-procedure follow-up [ Time Frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
- The rate of per-procedural subarachnoid hemorrhage of the treated aneurysm and rate of per-procedural SAH leading to a modification of the procedure initially planned [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
- The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: Yes ]
- The rate of aneurysm occlusion at the end of the procedure and at 1 year post-procedure follow-up [ Time Frame: End of the procedure and at 1 year post-procedure follow-up ] [ Designated as safety issue: No ]
- The rate of aneurysm recanalisation up to 1 year post-treatment defined as any increase in the size of the remnant or defined as a change of classification of the Raymond scale result related up to the 1 year post-procedure follow-up [ Time Frame: Up to 1 year post-treatment ] [ Designated as safety issue: No ]
- The rate of spontaneous aneurysm regression up to 1 year post-treatment defined as any decrease in the size of the remnant or defined as a change of classification of the Raymond scale result related up to the 1 year post-procedure follow-up [ Time Frame: Up to the 1 year post-procedure follow-up ] [ Designated as safety issue: No ]
- The rate of retreatment at 1 year follow-up representing the rate of major recurrence on the target aneurysm observed up to the 1 year post-procedure follow-up [ Time Frame: Up to the 1 year post-procedure follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 165 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| TRUFILL® DCS Orbit |
| TRUFILL® DCS Orbit Galaxy |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Routine clinical practice
Criteria
Inclusion Criteria:
- Patient ≥ 18 years old
- Patient presenting one or more ruptured or non-ruptured intracranial aneurysms assessed by angiography
- Patient implanted with one or more CODMAN TRUFILL® coils
- Patient agree to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and have received information letter.
Exclusion Criteria:
- Patient who does not accept to take part in the study after being informed
- Patient already enrolled in a clinical trial involving experimental medication or device.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503775
Contacts
| Contact: J. Thomas Megerian, MD, PhD | 1 508-880-8100 | jmergeri1@its.jnj.com |
| Contact: Arnaud NICOLAS | 33 1 55 00 45 43 | anicolas@its.jnj.com |
Locations
| France | |
| CHU Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France | |
| Hopitaux Civils de Colmar | Recruiting |
| Colmar, France | |
| Hôpital Neurologique | Recruiting |
| Lyon, France, 69394 | |
| Hôpital Adullte La Timone | Recruiting |
| Marseille, France | |
| Clinique Clairval | Recruiting |
| Marseille, France | |
| Fondation Rothschild | Recruiting |
| Paris, France | |
| CHU Pontchaillou | Recruiting |
| Rennes, France | |
Sponsors and Collaborators
Codman & Shurtleff
More Information
No publications provided
| Responsible Party: | Codman & Shurtleff |
| ClinicalTrials.gov Identifier: | NCT01503775 History of Changes |
| Other Study ID Numbers: | NV-PMK-0902 |
| Study First Received: | December 23, 2011 |
| Last Updated: | February 12, 2013 |
| Health Authority: | France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: Conseil National de l'Ordre des Médecins France: The Commission nationale de l’informatique et des libertés France: Institutional Ethical Committee |
Keywords provided by Codman & Shurtleff:
|
intracranial ruptured non-ruptured aneurysms Intracranial ruptured or non-ruptured aneurysms |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013