Trial Outcomes & Findings for Effects of Carotid Stent Design on Cerebral Embolization (NCT NCT00830232)

Results Overview

Bilateral transcranial Doppler scan monitoring of the anterior and middle cerebral arteries was performed using a PMD150-ST3 digital transcranial Doppler pulsed-wave ultrasound scan system (Spencer Technologies, Seattle, Wash) with 2-MHz probes located over the temporal bones above the zygomatic arch. Isolated microembolic signals (MES) were identified from Doppler spectras according to the criteria given by the Consensus Committee of the Ninth International Cerebral Hemodynamic Symposium. If the number of MES was too high to be counted separately, heartbeats with microemboli were counted as microembolic showers. To avoid confusion, MES detected during contrast injection were excluded from the analysis. For analysis purposes, the procedure was divided into the following phases: lesion crossing, filter deployment, IVUS examination, predilation, stent deployment, postdilatation (when applicable), and filter removal.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

First 24 hours after implantation of carotid stent

Results posted on

2020-02-05

Participant Flow

Patients recruitment was started on december 2008 and continued until February 2012. Patients recruitment and consenting were performed at the medical clinic.

Patients were considered officially enrolled after the randomization, which was performed during the procedure after the initial angiography (initial image of the brain blood flow).

Participant milestones

Participant milestones
Measure	Closed-cell Stent Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this group was the Xact closed-cell stent. This type of device is a rigid device with a dense composition between the nitinol rings. Carotid stenting was used on standard fashion using filters as embolic protection device.	Open-cell Stent Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent. Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Carotid Stent Design on Cerebral Embolization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Closed-cell Stent n=20 Participants closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.	Open-cell Stent n=20 Participants Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 8.07 • n=5 Participants	67 years STANDARD_DEVIATION 8.5 • n=7 Participants	66.7 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: First 24 hours after implantation of carotid stent

Bilateral transcranial Doppler scan monitoring of the anterior and middle cerebral arteries was performed using a PMD150-ST3 digital transcranial Doppler pulsed-wave ultrasound scan system (Spencer Technologies, Seattle, Wash) with 2-MHz probes located over the temporal bones above the zygomatic arch. Isolated microembolic signals (MES) were identified from Doppler spectras according to the criteria given by the Consensus Committee of the Ninth International Cerebral Hemodynamic Symposium. If the number of MES was too high to be counted separately, heartbeats with microemboli were counted as microembolic showers. To avoid confusion, MES detected during contrast injection were excluded from the analysis. For analysis purposes, the procedure was divided into the following phases: lesion crossing, filter deployment, IVUS examination, predilation, stent deployment, postdilatation (when applicable), and filter removal.

Outcome measures

Outcome measures
Measure	Closed-cell Stent n=20 Participants closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.	Open-cell Stent n=20 Participants Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery.	264 Micro-emboli Interval 222.0 to 343.0	339 Micro-emboli Interval 163.0 to 408.0

SECONDARY outcome

Timeframe: within 30 days after the carotid stenting procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 24 hours after carotid artery stenting

Outcome measures

Outcome data not reported

Adverse Events

Closed-cell Stent

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Open-cell Stent

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Closed-cell Stent n=20 participants at risk closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.	Open-cell Stent n=20 participants at risk Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
Cardiac disorders Non-ST elevation myocardial infarction (NSTEMI)	10.0% 2/20 • Number of events 2 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study	0.00% 0/20 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study
Vascular disorders Groin Hematoma	0.00% 0/20 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study	5.0% 1/20 • Number of events 1 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study
Vascular disorders Peri-operative hypotension	15.0% 3/20 • Number of events 3 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study	0.00% 0/20 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study
Nervous system disorders Aphasia	0.00% 0/20 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study	5.0% 1/20 • Number of events 1 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study
Cardiac disorders Angina	5.0% 1/20 • Number of events 1 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study	0.00% 0/20 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study
Vascular disorders Stroke	0.00% 0/20 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study	5.0% 1/20 • Number of events 1 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study
Nervous system disorders Transient Ischemic Atack	0.00% 0/20 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study	5.0% 1/20 • Number of events 1 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study
Renal and urinary disorders Nephrolithiasis	5.0% 1/20 • Number of events 1 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study	0.00% 0/20 • Assessment for adverse events was perfumed at 30 days after carotid stenting. Only serious adverse events were collected/assessed for this study

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carlos H Timaran

Dallas VA Medical Center

Phone: 2148570336

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place