Trial Outcomes & Findings for SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy (NCT NCT01591005)

Results Overview

The number of participants with a new brain infarctions in sonolysis group detected using magnetic resonance examination 24 hours after carotid endarterectomy or carotid stenting. Substudy: The number of participants with a new brain infarctions on brain diffusion-weighted magnetic resonance imaging performed 24 hours after intervention in carotid endarterectomy and carotid stenting groups.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

242 participants

Primary outcome timeframe

24 hours after intervention

Results posted on

2016-09-08

Participant Flow

Participant milestones

Participant milestones
Measure	CEA With Sonolysis endarterectomy with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes endarterectomy: carotid endarterectomy	CEA Without Sonolysis endarterectomy without sonolysis endarterectomy: carotid endarterectomy	Carotid Stenting With Sonolysis carotid stenting with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes carotid stenting: percutaneous transluminal angioplasty and stenting	Carotid Stenting Without Sonolysis carotid stenting without sonolysis carotid stenting: percutaneous transluminal angioplasty and stenting
Overall Study STARTED	53	53	68	68
Overall Study COMPLETED	53	53	68	68
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CEA With Sonolysis n=53 Participants endarterectomy with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes endarterectomy: carotid endarterectomy	CEA Without Sonolysis n=53 Participants endarterectomy without sonolysis endarterectomy: carotid endarterectomy	Carotid Stenting With Sonolysis n=68 Participants carotid stenting with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes carotid stenting: percutaneous transluminal angioplasty and stenting	Carotid Stenting Without Sonolysis n=68 Participants carotid stenting without sonolysis carotid stenting: percutaneous transluminal angioplasty and stenting	Total n=242 Participants Total of all reporting groups
Age, Continuous	64.0 years STANDARD_DEVIATION 7.3 • n=93 Participants	63.0 years STANDARD_DEVIATION 7.5 • n=4 Participants	66.8 years STANDARD_DEVIATION 6.7 • n=27 Participants	68.5 years STANDARD_DEVIATION 7.7 • n=483 Participants	65.8 years STANDARD_DEVIATION 7.6 • n=36 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	21 Participants n=4 Participants	15 Participants n=27 Participants	24 Participants n=483 Participants	80 Participants n=36 Participants
Sex: Female, Male Male	33 Participants n=93 Participants	32 Participants n=4 Participants	53 Participants n=27 Participants	44 Participants n=483 Participants	162 Participants n=36 Participants
Region of Enrollment Czech Republic	53 participants n=93 Participants	53 participants n=4 Participants	68 participants n=27 Participants	68 participants n=483 Participants	242 participants n=36 Participants

PRIMARY outcome

Timeframe: 24 hours after intervention

The number of participants with a new brain infarctions in sonolysis group detected using magnetic resonance examination 24 hours after carotid endarterectomy or carotid stenting. Substudy: The number of participants with a new brain infarctions on brain diffusion-weighted magnetic resonance imaging performed 24 hours after intervention in carotid endarterectomy and carotid stenting groups.

Outcome measures

Outcome measures
Measure	Carotid Endarterectomy With Sonolysis n=53 Participants endarterectomy with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes endarterectomy: carotid endarterectomy	Carotid Endarterectomy Without Sonolysis n=53 Participants endarterectomy without sonolysis endarterectomy: carotid endarterectomy	Carotid Stenting With Sonolysis n=68 Participants carotid stenting with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes carotid stenting: percutaneous transluminal angioplasty and stenting	Carotid Stenting Without Sonolysis n=68 Participants carotid stenting without sonolysis carotid stenting: percutaneous transluminal angioplasty and stenting
Participants With a New Brain Infarction Detected Using Magnetic Resonance	5 participants	15 participants	33 participants	42 participants

SECONDARY outcome

Timeframe: 24 hours after intervention

The number of participants with a new brain infarctions \>0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis. Substudy: The number of participants with a new brain infarctions \>0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups.

Outcome measures

Outcome measures
Measure	Carotid Endarterectomy With Sonolysis n=53 Participants endarterectomy with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes endarterectomy: carotid endarterectomy	Carotid Endarterectomy Without Sonolysis n=53 Participants endarterectomy without sonolysis endarterectomy: carotid endarterectomy	Carotid Stenting With Sonolysis n=68 Participants carotid stenting with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes carotid stenting: percutaneous transluminal angioplasty and stenting	Carotid Stenting Without Sonolysis n=68 Participants carotid stenting without sonolysis carotid stenting: percutaneous transluminal angioplasty and stenting
Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups	3 participants	7 participants	3 participants	17 participants

SECONDARY outcome

Timeframe: 24 hours after intervention

Population: only patients with performed Mini Mental State examination

The changes in cognitive functions after carotid endarterectomy and carotid stenting measured by Mini-Mental State Examination using periprocedural sonolysis. Substudy: The changes in cognitive functions after intervention measured by Mini-Mental State Examination between carotid endarterectomy and carotid stenting groups. Range of scores possible for the Mini-Mental State Examination: 0 - 30 points. Higher values in this range are considered to be a better outcome.

Outcome measures

Outcome measures
Measure	Carotid Endarterectomy With Sonolysis n=35 Participants endarterectomy with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes endarterectomy: carotid endarterectomy	Carotid Endarterectomy Without Sonolysis n=37 Participants endarterectomy without sonolysis endarterectomy: carotid endarterectomy	Carotid Stenting With Sonolysis n=47 Participants carotid stenting with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes carotid stenting: percutaneous transluminal angioplasty and stenting	Carotid Stenting Without Sonolysis n=46 Participants carotid stenting without sonolysis carotid stenting: percutaneous transluminal angioplasty and stenting
Cognitive Decline	28 Scores on a scale Interval 26.0 to 29.0	27 Scores on a scale Interval 25.0 to 28.0	28 Scores on a scale Interval 26.0 to 29.0	27 Scores on a scale Interval 25.0 to 29.0

SECONDARY outcome

Timeframe: 24 hours and 30 days after intervention

The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system during carotid endarterectomy and carotid stenting using periprocedural sonolysis. Substudy: The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system between carotid endarterectomy and carotid stenting groups.

Outcome measures

Outcome measures
Measure	Carotid Endarterectomy With Sonolysis n=53 Participants endarterectomy with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes endarterectomy: carotid endarterectomy	Carotid Endarterectomy Without Sonolysis n=53 Participants endarterectomy without sonolysis endarterectomy: carotid endarterectomy	Carotid Stenting With Sonolysis n=68 Participants carotid stenting with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes carotid stenting: percutaneous transluminal angioplasty and stenting	Carotid Stenting Without Sonolysis n=68 Participants carotid stenting without sonolysis carotid stenting: percutaneous transluminal angioplasty and stenting
Number of Participants With Clinical Manifested Brain Infarction	1 participants	0 participants	0 participants	3 participants

SECONDARY outcome

Timeframe: 24 hours after intervention

The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis. Substudy: The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups.

Outcome measures

Outcome measures
Measure	Carotid Endarterectomy With Sonolysis n=53 Participants endarterectomy with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes endarterectomy: carotid endarterectomy	Carotid Endarterectomy Without Sonolysis n=53 Participants endarterectomy without sonolysis endarterectomy: carotid endarterectomy	Carotid Stenting With Sonolysis n=68 Participants carotid stenting with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes carotid stenting: percutaneous transluminal angioplasty and stenting	Carotid Stenting Without Sonolysis n=68 Participants carotid stenting without sonolysis carotid stenting: percutaneous transluminal angioplasty and stenting
Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups	5 participants	14 participants	26 participants	38 participants

SECONDARY outcome

Timeframe: 30 days after intervention

The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase \>2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) after carotid endarterectomy and carotid stenting using periprocedural sonolysis. Substudy: The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase \>2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) between carotid endarterectomy and carotid stenting groups.

Outcome measures

Outcome measures
Measure	Carotid Endarterectomy With Sonolysis n=53 Participants endarterectomy with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes endarterectomy: carotid endarterectomy	Carotid Endarterectomy Without Sonolysis n=53 Participants endarterectomy without sonolysis endarterectomy: carotid endarterectomy	Carotid Stenting With Sonolysis n=68 Participants carotid stenting with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes carotid stenting: percutaneous transluminal angioplasty and stenting	Carotid Stenting Without Sonolysis n=68 Participants carotid stenting without sonolysis carotid stenting: percutaneous transluminal angioplasty and stenting
Number of Participants With Clinical Vascular Event or Death	0 participants	0 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours and 30 days after intervention

Any complication during carotid endarterectomy and carotid stenting, sonolysis or 30 days after intervention in all subgroups.

Outcome measures

Outcome measures
Measure	Carotid Endarterectomy With Sonolysis n=53 Participants endarterectomy with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes endarterectomy: carotid endarterectomy	Carotid Endarterectomy Without Sonolysis n=53 Participants endarterectomy without sonolysis endarterectomy: carotid endarterectomy	Carotid Stenting With Sonolysis n=68 Participants carotid stenting with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes carotid stenting: percutaneous transluminal angioplasty and stenting	Carotid Stenting Without Sonolysis n=68 Participants carotid stenting without sonolysis carotid stenting: percutaneous transluminal angioplasty and stenting
Number of Participants With Complications	0 participants	0 participants	0 participants	0 participants

Adverse Events

CEA With Sonolysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CEA Without Sonolysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carotid Stenting With Sonolysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carotid Stenting Without Sonolysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. David Skoloudik, MD, Ph.D.

University Hospital Ostrava

Phone: +420597375613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place