Trial Outcomes & Findings for PRET: Patients Prone to Recurrence After Endovascular Treatment (NCT NCT00626912)

Last Updated: 2019-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

447 participants

Primary outcome timeframe

18 months

Results posted on

2019-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Platinum Coils Endovascular coil embolization with standard platinum coils	Hydrogel Coils Endovascular Coil embolization with Hydrogel Coils
Overall Study STARTED	222	225
Overall Study COMPLETED	220	215
Overall Study NOT COMPLETED	2	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Platinum Coils n=222 Participants Endovascular coil embolization with standard platinum coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques	Hydrogel Coils n=225 Participants Endovascular coil embolization with hydrogel coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques	Total n=447 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 12 • n=222 Participants	57 years STANDARD_DEVIATION 11 • n=225 Participants	58 years STANDARD_DEVIATION 11 • n=447 Participants
Sex: Female, Male Female	154 Participants n=222 Participants	165 Participants n=225 Participants	319 Participants n=447 Participants
Sex: Female, Male Male	68 Participants n=222 Participants	60 Participants n=225 Participants	128 Participants n=447 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	75 Participants n=222 Participants	61 Participants n=225 Participants	136 Participants n=447 Participants
Region of Enrollment United States	112 Participants n=222 Participants	126 Participants n=225 Participants	238 Participants n=447 Participants
Region of Enrollment Japan	3 Participants n=222 Participants	1 Participants n=225 Participants	4 Participants n=447 Participants
Region of Enrollment United Kingdom	10 Participants n=222 Participants	12 Participants n=225 Participants	22 Participants n=447 Participants
Region of Enrollment France	15 Participants n=222 Participants	18 Participants n=225 Participants	33 Participants n=447 Participants
Region of Enrollment Chile	7 Participants n=222 Participants	7 Participants n=225 Participants	14 Participants n=447 Participants
Ruptured aneurysms (Number)	39 Participants n=222 Participants	40 Participants n=225 Participants	79 Participants n=447 Participants
Aneurysm size (mean (SD))	11.3 millimeters STANDARD_DEVIATION 5.8 • n=222 Participants	10.7 millimeters STANDARD_DEVIATION 5.3 • n=225 Participants	11.0 millimeters STANDARD_DEVIATION 5.6 • n=447 Participants

PRIMARY outcome

Timeframe: 18 months

Population: For the Platinum coils population (222): Primary outcome available for 220/222 (could not attribute primary outcome for 2 participants) For the Hydrogel coils population (225): Withdrawn by physician right after Registration: 3/225 (remaining 222) Primary outcome available for 215/222 (could not attribute primary outcome for 7 participants)

Outcome measures

Outcome measures
Measure	Platinum Coils n=220 Participants platinum coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques	Hydrogel Coils n=215 Participants hydrogel coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques
Recurrence Rate of Target Aneurysm.	102 Participants	103 Participants

SECONDARY outcome

Timeframe: 18 months

Population: For the Platinum coils population (222): Secondary outcome measure applies to 222 participants. For the Hydrogel coils population (225): Withdrawn by physician right after Registration: 3/225 (remaining 222). Secondary outcome measure applies to 222 participants

Number of participants dead - All causes

Outcome measures

Outcome measures
Measure	Platinum Coils n=222 Participants platinum coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques	Hydrogel Coils n=222 Participants hydrogel coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques
Mortality Rate	3 Participants	13 Participants

SECONDARY outcome

Timeframe: 18 months

Number of participants having experienced one or several Adverse Events. This measure is the number of participants having experienced Serious Adverse Events plus those having experienced other (not including Serious) Adverse Events.

Outcome measures

Outcome measures
Measure	Platinum Coils n=222 Participants platinum coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques	Hydrogel Coils n=222 Participants hydrogel coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques
Number of Participants With Adverse Events	37 Participants	41 Participants

SECONDARY outcome

Timeframe: 18 months

Number of participants having experienced one or several Serious Adverse Events

Outcome measures

Outcome measures
Measure	Platinum Coils n=222 Participants platinum coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques	Hydrogel Coils n=222 Participants hydrogel coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques
Number of Participants With Serious Adverse Events	20 Participants	25 Participants

Adverse Events

Platinum Coils

Serious events: 20 serious events

Other events: 17 other events

Deaths: 3 deaths

Hydrogel Coils

Serious events: 25 serious events

Other events: 16 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Platinum Coils n=222 participants at risk platinum coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques	Hydrogel Coils n=222 participants at risk hydrogel coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques
Vascular disorders sub-arachnoid hemorrhage	0.90% 2/222 • Number of events 2 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.90% 2/222 • Number of events 2 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Vascular disorders Mass Effect	0.45% 1/222 • Number of events 1 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.45% 1/222 • Number of events 1 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Vascular disorders stroke	0.90% 2/222 • Number of events 2 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.90% 2/222 • Number of events 2 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Vascular disorders subdural hematoma	0.00% 0/222 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.45% 1/222 • Number of events 1 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Vascular disorders non neurologic	0.90% 2/222 • Number of events 2 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.00% 0/222 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Surgical and medical procedures Retreatment related	0.00% 0/222 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	2.3% 5/222 • Number of events 5 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Surgical and medical procedures periprocedure event	5.9% 13/222 • Number of events 13 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	6.3% 14/222 • Number of events 14 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.

Other adverse events

Other adverse events
Measure	Platinum Coils n=222 participants at risk platinum coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques	Hydrogel Coils n=222 participants at risk hydrogel coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques
Vascular disorders Transient Ischemic Attack	0.00% 0/222 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.45% 1/222 • Number of events 1 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Vascular disorders Mass Effect	0.45% 1/222 • Number of events 1 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.00% 0/222 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Vascular disorders Inflammatory	0.90% 2/222 • Number of events 2 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.00% 0/222 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Vascular disorders Non neurologic	0.45% 1/222 • Number of events 1 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.45% 1/222 • Number of events 1 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Surgical and medical procedures Retreatment related	1.4% 3/222 • Number of events 3 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	0.00% 0/222 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Surgical and medical procedures Periprocedure event	4.5% 10/222 • Number of events 10 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.	6.3% 14/222 • Number of events 14 • 18 months an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.

Additional Information

Ruby Klink, coordinator

Centre de Recherches du Centre Hospitalier de l'Université de Montréal

Phone: (514) 890 8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place