Trials Sponsors Conditions Drugs Pricing

Conditions

Intracranial Aneurysm Subarachnoid Hemorrhage

Keywords

large aneurysmrecurrencehydrocoil

Outcome Measures

Primary Outcomes (1)

Recurrence Rate of Target Aneurysm.
1. major angiographic recurrence of the lesion or the presence of a residual aneurysm at last angiographic follow-up, as determined by the core laboratory, blinded to treatment allocation; 2. retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 3. an intracranial bleeding episode, or the occurrence or progression of a mass effect in relation to the treated aneurysm during the follow-up period, as determined by the blinded Adverse Event Committee.
18 months

Secondary Outcomes (3)

Mortality Rate
18 months
Number of Participants With Adverse Events
18 months
Number of Participants With Serious Adverse Events
18 months

Study Arms (2)

1

ACTIVE COMPARATOR

platinum coils

Procedure: endovascular coil embolization

2

ACTIVE COMPARATOR

hydrogel coils

Procedure: endovascular coil embolization

Interventions

endovascular coil embolizationProcedure

standard endovascular coil embolization with or without adjunct techniques

Also known as: platinum coil, hydrogel coil

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All patients presenting at least one aneurysm 'prone to recurrence after endovascular treatment' (PRET), defined for the sake of this study as:
PRET-1: One ruptured or unruptured aneurysm, never treated, with a dimension ≥10mm (longest axis, including thrombosed portions of large or giant aneurysms); for ruptured lesions, patients should be in WFNS grade I, II or III.

Sponsors & Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)
Otherlead

Study Sites (32)

Shands - University of Florida Hospital

Gainesville, Florida, United States

Borgess Medical Center

Kalamazoo, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

University of Mississipi Health Care

Jackson, Mississippi, 39216, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Washington University in St Louis

St Louis, Missouri, United States

University of Buffalo (SUNY)

Buffalo, New York, United States

Related Publications (1)

Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available.
PMID: 24849854DERIVED

MeSH Terms

Conditions

Intracranial AneurysmSubarachnoid HemorrhageRecurrence

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Operators could not be blinded to coil type. This may have affected case selection, coil selection, and completeness of the coiling procedure. Aneurysm volumes were not directly measured but extrapolated from aneurysm dimensions.

Results Point of Contact

Title: Ruby Klink, coordinator
Organization: Centre de Recherches du Centre Hospitalier de l'Université de Montréal

Study Officials

Jean RAYMOND, MD
Centre hospitalier de l'Université de Montréal (CHUM)
STUDY CHAIR
Daniel ROY, MD
Centre hospitalier de l'Université de Montréal (CHUM)
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

447 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 21, 2008

First Posted

February 29, 2008

Study Start

June 2007

Date type not reported

This date has not been verified as actual or estimated.

PRET: Patients Prone to Recurrence After Endovascular Treatment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (32)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (32)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations