Trial Outcomes & Findings for Proximal Protection With The Mo.Ma Device During Carotid Stenting (NCT NCT00744523)

Last Updated: 2016-02-26

Results Overview

Number of subjects with one or more Major Adverse Cardiac and Cerebrovascular Events through 30 days after the procedure. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.

Recruitment status

COMPLETED

Study phase

Target enrollment

262 participants

Primary outcome timeframe

Up to 30 days after the procedure was performed

Results posted on

2016-02-26

Participant Flow

The trial was approved to enroll subjects from a maximum of 25 (combined United States \[US\] and European Union \[EU\]) medical institutions (public and academic research center hospitals). Subjects were enrolled from September 2007 to February 2009.

Participant milestones

Participant milestones
Measure	MO.MA Roll-In Cases All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
Procedure STARTED	37	225
Procedure COMPLETED	37	225
Procedure NOT COMPLETED	0	0
30 Days After the Procedure STARTED	37	225
30 Days After the Procedure COMPLETED	37	220
30 Days After the Procedure NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	MO.MA Roll-In Cases All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
30 Days After the Procedure Insufficient follow-up	0	5

Baseline Characteristics

Proximal Protection With The Mo.Ma Device During Carotid Stenting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MO.MA Roll-In Cases n=37 Participants All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects n=225 Participants All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	Total n=262 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants	37 Participants n=4 Participants	43 Participants n=27 Participants
Age, Categorical >=65 years	31 Participants n=93 Participants	188 Participants n=4 Participants	219 Participants n=27 Participants
Age, Customized < 80 years	26 participants n=93 Participants	160 participants n=4 Participants	186 participants n=27 Participants
Age, Customized >= 80 years	11 participants n=93 Participants	65 participants n=4 Participants	76 participants n=27 Participants
Age, Continuous	74.28 years STANDARD_DEVIATION 10.38 • n=93 Participants	74.66 years STANDARD_DEVIATION 8.54 • n=4 Participants	74.61 years STANDARD_DEVIATION 8.80 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	75 Participants n=4 Participants	87 Participants n=27 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	150 Participants n=4 Participants	175 Participants n=27 Participants
Region of Enrollment United States	37 participants n=93 Participants	147 participants n=4 Participants	184 participants n=27 Participants
Region of Enrollment Europe	0 participants n=93 Participants	78 participants n=4 Participants	78 participants n=27 Participants
History of Diabetes Yes	15 participants n=93 Participants	83 participants n=4 Participants	98 participants n=27 Participants
History of Diabetes No	21 participants n=93 Participants	141 participants n=4 Participants	162 participants n=27 Participants
History of Diabetes No Response	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
History of Hypertension Yes	32 participants n=93 Participants	196 participants n=4 Participants	228 participants n=27 Participants
History of Hypertension No	5 participants n=93 Participants	29 participants n=4 Participants	34 participants n=27 Participants
Symptomatic [1] Symptomatic	8 participants n=93 Participants	34 participants n=4 Participants	42 participants n=27 Participants
Symptomatic [1] Asymptomatic	29 participants n=93 Participants	191 participants n=4 Participants	220 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 30 days after the procedure was performed

Population: Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.

Outcome measures

Outcome measures
Measure	MO.MA Training Cases (Roll-In) n=37 Participants All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects n=225 Participants All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. Any MACCE during 30 days after the procedure	0 participants	6 participants
Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. Any myocardial infarction	0 participants	0 participants
Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. Stroke	0 participants	5 participants
Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. Death	0 participants	2 participants
Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. Any MACCE during the procedure	0 participants	4 participants
Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. Any MACCE at discharge	0 participants	4 participants

SECONDARY outcome

Timeframe: The entire duration of the index procedure

Population: Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria who were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.

Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure.

Outcome measures

Outcome measures
Measure	MO.MA Training Cases (Roll-In) n=37 Participants All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects n=225 Participants All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
Device Success	37 participants	221 participants

SECONDARY outcome

Timeframe: The entire duration of the index procedure

Population: Roll-In participants were analysed on the number of roll-in cases performed. Pivotal subjects were analysed as Intention To Treat (ITT).

Number of subjects with device success and the ability to successfully implant a carotid stent and obtain a residual stenosis \< 30% during the index procedure(as evaluated by the angiographic core laboratory). Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222.

Outcome measures

Outcome measures
Measure	MO.MA Training Cases (Roll-In) n=36 Participants All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects n=222 Participants All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
Technical Success	34 participants	210 participants

SECONDARY outcome

Timeframe: The entire duration of the index procedure through hospital discharge

Number of subjects with technical success without the occurrence of any MACCE or unresolved antegrade flow blockage intolerance during the index hospitalization. Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222.

Outcome measures

Outcome measures
Measure	MO.MA Training Cases (Roll-In) n=36 Participants All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects n=222 Participants All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
Procedural Success	33 participants	207 participants

SECONDARY outcome

Timeframe: Up to 30 days after the procedure was performed

Number of subjects with re-narrowing of the lesion at 30 days as defined as a \>= 50% stenosis measured by duplex ultrasound scan.

Outcome measures

Outcome measures
Measure	MO.MA Training Cases (Roll-In) n=34 Participants All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects n=190 Participants All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
Restenosis at 30 Days	2 participants	3 participants

SECONDARY outcome

Timeframe: Up to 30 days after the procedure was performed

Number of subjects with any repeat invasive procedure, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase lumen diameter inside or within 10 mm of the previously treated lesion.

Outcome measures

Outcome measures
Measure	MO.MA Training Cases (Roll-In) n=37 Participants All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects n=220 Participants All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
Target Lesion Revascularization at 30 Days	0 participants	0 participants

SECONDARY outcome

Timeframe: Index Procedure through Hospital Discharge

Number of subjects with adverse events at the percutaneous access site as a result of the index procedure, including bruising, hematoma and bleeding requiring treatment by transfusion of blood products, surgical repair, ultrasound compression or thrombin injection.

Outcome measures

Outcome measures
Measure	MO.MA Training Cases (Roll-In) n=37 Participants All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects n=225 Participants All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
Access Site Adverse Events	2 participants	7 participants

Adverse Events

MO.MA Roll-In Cases

Serious events: 11 serious events

Other events: 27 other events

Deaths: 0 deaths

MO.MA Pivotal Subjects

Serious events: 37 serious events

Other events: 132 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Arslan Malik, Senior Clinical Research Manager

Medtronic Aortic and Peripheral Vascular

Phone: (707) 541-3256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	MO.MA Roll-In Cases n=37 participants at risk All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device	MO.MA Pivotal Subjects n=225 participants at risk All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
Blood and lymphatic system disorders Anaemia	— 0/0 • Index procedure through the 30 day follow-up visit.	1.8% 4/225 • Number of events 4 • Index procedure through the 30 day follow-up visit.
Investigations Blood urea increased	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Cardiac disorders Bradycardia	2.7% 1/37 • Number of events 1 • Index procedure through the 30 day follow-up visit.	0.89% 2/225 • Number of events 2 • Index procedure through the 30 day follow-up visit.
Cardiac disorders Cardiac failure congestive	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Cardiac disorders Cardio-respiratory arrest	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Nervous system disorders Carotid artery stenosis	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
General disorders Catheter site haemorrhage	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Nervous system disorders Cerebral hyperfusion syndrome	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Nervous system disorders Cerebrovascular accident	— 0/0 • Index procedure through the 30 day follow-up visit.	0.89% 2/225 • Number of events 3 • Index procedure through the 30 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.7% 1/37 • Number of events 1 • Index procedure through the 30 day follow-up visit.	— 0/0 • Index procedure through the 30 day follow-up visit.
Blood and lymphatic system disorders Coagulopathy	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Nervous system disorders Confusional state	2.7% 1/37 • Number of events 1 • Index procedure through the 30 day follow-up visit.	— 0/0 • Index procedure through the 30 day follow-up visit.
Nervous system disorders Convulsion	2.7% 1/37 • Number of events 1 • Index procedure through the 30 day follow-up visit.	— 0/0 • Index procedure through the 30 day follow-up visit.
Cardiac disorders Coronary artery disease	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Gastrointestinal disorders Diverticular perforation	2.7% 1/37 • Number of events 1 • Index procedure through the 30 day follow-up visit.	— 0/0 • Index procedure through the 30 day follow-up visit.
Investigations Ejection fraction abnormal	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Nervous system disorders Embolic stroke	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Vascular disorders Femoral artery occlusion	2.7% 1/37 • Number of events 1 • Index procedure through the 30 day follow-up visit.	— 0/0 • Index procedure through the 30 day follow-up visit.
Gastrointestinal disorders Gastrointestinal haemorrhage	— 0/0 • Index procedure through the 30 day follow-up visit.	0.89% 2/225 • Number of events 2 • Index procedure through the 30 day follow-up visit.
Gastrointestinal disorders Haematemesis	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Investigations Haemoglobin decreased	— 0/0 • Index procedure through the 30 day follow-up visit.	0.89% 2/225 • Number of events 2 • Index procedure through the 30 day follow-up visit.
Injury, poisoning and procedural complications Hip fracture	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Vascular disorders Hypotension	18.9% 7/37 • Number of events 7 • Index procedure through the 30 day follow-up visit.	2.7% 6/225 • Number of events 6 • Index procedure through the 30 day follow-up visit.
Vascular disorders Iliac artery occlusion	2.7% 1/37 • Number of events 1 • Index procedure through the 30 day follow-up visit.	— 0/0 • Index procedure through the 30 day follow-up visit.
Nervous system disorders Ischaemic stroke	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Nervous system disorders Loss of consciousness	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Injury, poisoning and procedural complications Lumbar vertebral fracture	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
General disorders Multi-organ failure	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Musculoskeletal and connective tissue disorders Neck pain	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Vascular disorders Orthostatic hypotension	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Infections and infestations Pneumonia	— 0/0 • Index procedure through the 30 day follow-up visit.	0.89% 2/225 • Number of events 2 • Index procedure through the 30 day follow-up visit.
Renal and urinary disorders Renal failure	— 0/0 • Index procedure through the 30 day follow-up visit.	1.3% 3/225 • Number of events 3 • Index procedure through the 30 day follow-up visit.
Renal and urinary disorders Renal failure acute	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Nervous system disorders Syncope	— 0/0 • Index procedure through the 30 day follow-up visit.	0.89% 2/225 • Number of events 2 • Index procedure through the 30 day follow-up visit.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.7% 1/37 • Number of events 1 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Renal and urinary disorders Urethral stenosis	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Renal and urinary disorders Urinary retention	— 0/0 • Index procedure through the 30 day follow-up visit.	0.44% 1/225 • Number of events 1 • Index procedure through the 30 day follow-up visit.
Vascular disorders Vascular pseudoaneurysm	— 0/0 • Index procedure through the 30 day follow-up visit.	0.89% 2/225 • Number of events 2 • Index procedure through the 30 day follow-up visit.
Cardiac disorders Ventricular tachycardia	2.7% 1/37 • Number of events 1 • Index procedure through the 30 day follow-up visit.	— 0/0 • Index procedure through the 30 day follow-up visit.