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Stenting in the Treatment of Aneurysm Trial (STAT)

Primary Purpose

Intracranial Aneurysm

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

endovascular coiling with any type of currently approved coil (first or second generation)

endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring large aneurysm, wide-necked aneurysm, recurring aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients presenting at least one aneurysm candidate for coiling, with large (≥10mm), wide-necked (>4mm), or recurrent lesions after coiling (but not stenting) and judged by the neurovascular team to require elective treatment provided that this single lesion, and no other aneurysm, will be treated during the endovascular session to be the object of the trial
The anatomy of the lesion is such that endovascular treatment is judged possible with or without stenting
The endovascular physician is a priori content to use either type of technique
The patient has not previously been randomized into the trial
Treatment is elective
Patient is 18 or older
Life expectancy is more than 2 years
Patient has given fully informed consent and has signed consent form

Exclusion Criteria:

Other aneurysms requiring treatment during the same session
Patients with associated cerebral arteriovenous malformations
Patients with recently ruptured aneurysms
When parent vessel occlusion is the primary intent of the procedure
Any absolute contraindication to endovascular treatment, angiography, or anesthesia such as severe allergies to contrast or medications, including ASA and Clopidogrel
Patients with recurring, previously stented aneurysms

Sites / Locations

University of Alberta Hospital
Queen Elizabeth II Health Sciences Centre
The Ottawa Hospital
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
CHRU de Brest (Brest University Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

coiling

coiling plus stenting

Arm Description

endovascular coiling with any type of currently approved coil (first or second generation)

endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.

Outcomes

Primary Outcome Measures

Recurrence rate of target aneurysm

rate of angiographic recurrence

Secondary Outcome Measures

Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events

Periprocedural Adverse Events is any type of complication or Adverse Event reported during or in the 30 days following the intervention

Rate of mortality and morbidity defined as the number of subjects with a disabling neurological events as measured by a modified Rankin Score greater than 2 during the follow-up period

A morbid event is defined as any Adverse Event of any severity being possibly or probably related to the disease or the treatment

Overall morbidity and mortality given by the modified Rankin Score

Overall morbidity and mortality is defined as a change in modified Rankin Score relative to baseline

Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50%

luminal diameter will be evaluated by an independent Core Lab

Full Information

NCT ID

NCT01340612

First Posted

April 20, 2011

Last Updated

July 4, 2023

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

University Hospital, Brest

1. Study Identification

Unique Protocol Identification Number

NCT01340612

Brief Title

Stenting in the Treatment of Aneurysm Trial

Acronym

STAT

Official Title

Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 25, 2011 (Actual)

Primary Completion Date

January 2023 (Actual)

Study Completion Date

April 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

University Hospital, Brest

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The STAT trial aims at comparing coiling versus coiling plus stenting in patients with aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to coiling alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysm

Keywords

large aneurysm, wide-necked aneurysm, recurring aneurysm

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

205 (Actual)

8. Arms, Groups, and Interventions

Arm Title

coiling

Arm Type

Active Comparator

Arm Description

endovascular coiling with any type of currently approved coil (first or second generation)

Arm Title

coiling plus stenting

Arm Type

Active Comparator

Arm Description

endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.

Intervention Type

Device

Intervention Name(s)

endovascular coiling with any type of currently approved coil (first or second generation)

Intervention Description

Standard procedure for endovascular coiling.Coils may be bare Platinum coils or any so-called second generation coils such as but not restricted to Hydrocoil or Cerecyte

Intervention Type

Device

Intervention Name(s)

endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.

Intervention Description

Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician

Primary Outcome Measure Information:

Title

Recurrence rate of target aneurysm

Description

rate of angiographic recurrence

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events

Description

Periprocedural Adverse Events is any type of complication or Adverse Event reported during or in the 30 days following the intervention

Time Frame

30 days

Title

Rate of mortality and morbidity defined as the number of subjects with a disabling neurological events as measured by a modified Rankin Score greater than 2 during the follow-up period

Description

A morbid event is defined as any Adverse Event of any severity being possibly or probably related to the disease or the treatment

Time Frame

12 months

Title

Overall morbidity and mortality given by the modified Rankin Score

Description

Overall morbidity and mortality is defined as a change in modified Rankin Score relative to baseline

Time Frame

12 months

Title

Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50%

Description

luminal diameter will be evaluated by an independent Core Lab

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients presenting at least one aneurysm candidate for coiling, with large (≥10mm), wide-necked (>4mm), or recurrent lesions after coiling (but not stenting) and judged by the neurovascular team to require elective treatment provided that this single lesion, and no other aneurysm, will be treated during the endovascular session to be the object of the trial The anatomy of the lesion is such that endovascular treatment is judged possible with or without stenting The endovascular physician is a priori content to use either type of technique The patient has not previously been randomized into the trial Treatment is elective Patient is 18 or older Life expectancy is more than 2 years Patient has given fully informed consent and has signed consent form Exclusion Criteria: Other aneurysms requiring treatment during the same session Patients with associated cerebral arteriovenous malformations Patients with recently ruptured aneurysms When parent vessel occlusion is the primary intent of the procedure Any absolute contraindication to endovascular treatment, angiography, or anesthesia such as severe allergies to contrast or medications, including ASA and Clopidogrel Patients with recurring, previously stented aneurysms

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Raymond, MD

Organizational Affiliation

Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

Queen Elizabeth II Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

Country

Canada

Facility Name

The Ottawa Hospital

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

CHRU de Brest (Brest University Hospital)

City

Brest

ZIP/Postal Code

29 609 Brest

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

24849854

Citation

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.

Results Reference

derived

PubMed Identifier

21990519

Citation

Darsaut TE, Raymond J; STAT Collaborative Group. The design of the STenting in Aneurysm Treatments (STAT) trial. J Neurointerv Surg. 2012 May;4(3):178-81. doi: 10.1136/neurintsurg-2011-010065. Epub 2011 Jun 23.

Results Reference

derived

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Stenting in the Treatment of Aneurysm Trial

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