Carotid Artery Disease
Conditions
Keywords
carotid artery stenting, stroke, cerebral protection, high surgical risk
Brief summary
The objective of the ARMOUR study is to evaluate the safety and effectiveness of the Mo.Ma proximal flow blockage cerebral protection device for patients at high surgical risk for carotid endarterectomy who undergo carotid artery stenting
Detailed description
Test Device: Mo.Ma™ Proximal Flow Blockage Cerebral Protection Device. Single size catheter device with a 9 French introducer sheath compatible shaft (outer diameter) and a 6 French compatible working channel (inner diameter), integrating two compliant balloons intended to achieve endovascular clamping of external carotid arteries (ECA) 3-6 mm in diameter and common carotid arteries (CCA) 5-13 mm in diameter. Primary Objective: Evaluate the safety and effectiveness of the Mo.Ma device for cerebral protection in the treatment of internal carotid artery (ICA) stenoses, which may or may not involve the bifurcation of the CCA, in subjects considered to be at high surgical risk for complications during carotid endarterectomy (CEA). Primary Endpoint: Major adverse cardiac and cerebrovascular events (MACCE) within 30 days of implantation. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.
Interventions
DEVICEMo.Ma cerebral protection device
Proximal embolic protection based on the principle endovascular clamping consisting of a catheter with two compliant balloons. Mo.Ma is designed to achieve cerebral protection by proximal blood flow blockage at the carotid bifurcation: antegrade and retrograde flow blockage are achieved by proximal balloon occlusion of the CCA and distal balloon occlusion of the ECA. Cerebral protection is established prior to the initial wire passage through the stenosis and maintained during the entire procedure. Mo.Ma provides withdrawal of embolic particles by allowing manual syringe aspiration of any micro-emboli at the end of the procedure before restoring blood flow through the stented vessel.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General inclusion criteria Subject meets one or more of the high surgical risk criteria. * Subject is ≥ 18 years old. * Subject is a candidate for single lesion carotid artery stenting using a femoral arterial approach. * Subject is willing and able to comply with follow-up evaluations at the specified times. * Subject (or legal representative) understands the nature of the procedure and provides informed consent, prior to enrollment in the study. * If female subject, is not currently pregnant and has stated that she has no intention of becoming pregnant during the study. Angiographic inclusion criteria (as determined ≤ 30 days prior to procedure): * Target lesion stenosis (% stenosis = (1-N/D) X 100)1, documented by selective angiography pre-intervention, is * ≥ 80% stenosis for asymptomatic subjects or * ≥ 50% stenosis for symptomatic subjects. Symptomatic is defined as carotid stenosis associated with ipsilateral transient or visual TIA evidenced byamaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral ischemic stroke within 6 months prior to enrollment. * Target lesion is within the internal carotid artery and/or involves the bifurcation of the CCA. * External carotid artery diameter where the Mo.Ma device will be positioned is 3-6 mm. * Common carotid artery diameter where the Mo.Ma device will be positioned is 5-13 mm. General
Exclusion criteria
* Subject has participated in, is participating in, or plans to participate in another clinical study that may affect either the pre-procedure or follow-up results. * Subject has chronic or paroxysmal atrial fibrillation that is not treated by Coumadin. * Subject has undergone prior stenting of the ipsilateral carotid artery. * Subject's life expectancy is less than twelve months. * Subject is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand. * Subject is suffering from dementia. * Subject has documented intolerance to BOTH heparin and Angiomax. * Subject has an allergy or contraindication to acetylsalicylic acid (ASA). * Subject has a documented allergy to the device materials. * Subject has a documented allergy to radiographic contrast that cannot be pre-treated. * Subject has a documented allergy or contraindication to BOTH clopidogrel and ticlopidine. * Subject has had active bleeding diathesis requiring blood transfusion within one (1) month prior to index procedure. * Subject has had an MI within 72 hours prior to carotid stenting. * Subject has had coronary artery bypass graft (CABG) or vascular surgery within 30 days PRIOR TO index procedure (percutaneous coronary intervention is permissible provided cardiac enzymes are normal within 24 hours of index procedure), OR has planned CABG, vascular surgery, percutaneous coronary intervention (PCI), or has other invasive medical procedures planned within 30 days AFTER index procedure.(Unplanned urgent or emergent procedures may be performed at anytime as clinically indicated). * Subject has a major residual neurological deficit (stroke scales: Barthel ≤ 60, NIH ≥ 15 or Rankin \> 3) at pre-procedure neurological exam. * Subject has had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to index procedure. * Subject has had a stroke or retinal artery occlusion within one (1) month prior to index procedure. * Subject had abnormal pre-intervention blood counts with platelets \< 50,000/cubic mm or \> 700,000/cubic mm or white blood cell count \< 3,000/cubic mm. * Subject has severe chronic renal failure (creatinine \> 2.5 mg/dl). * Subject is currently being treated for cerebral carcinoma or sarcoma. * Subject has peripheral vascular disease, which precludes safe femoral artery sheath insertion. * Subject is unable or unwilling to undergo insertion of a temporary pacemaker. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Up to 30 days after the procedure was performed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | The entire duration of the index procedure | 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. |
| Procedural Success | 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. |
| Device Success | The entire duration of the index procedure | Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure. |
| Target Lesion Revascularization at 30 Days | 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. |
| Access Site Adverse Events | 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. |
| Restenosis at 30 Days | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 37 |
| 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 | 225 |
| Total | 262 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 30 Days After the Procedure | Insufficient follow-up | 0 | 5 |
Baseline characteristics
| Characteristic | MO.MA Roll-In Cases | MO.MA Pivotal Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 188 Participants | 219 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 37 Participants | 43 Participants |
| Age, Continuous | 74.28 years STANDARD_DEVIATION 10.38 | 74.66 years STANDARD_DEVIATION 8.54 | 74.61 years STANDARD_DEVIATION 8.8 |
| Age, Customized < 80 years | 26 participants | 160 participants | 186 participants |
| Age, Customized >= 80 years | 11 participants | 65 participants | 76 participants |
| History of Diabetes No | 21 participants | 141 participants | 162 participants |
| History of Diabetes No Response | 1 participants | 1 participants | 2 participants |
| History of Diabetes Yes | 15 participants | 83 participants | 98 participants |
| History of Hypertension No | 5 participants | 29 participants | 34 participants |
| History of Hypertension Yes | 32 participants | 196 participants | 228 participants |
| Region of Enrollment Europe | 0 participants | 78 participants | 78 participants |
| Region of Enrollment United States | 37 participants | 147 participants | 184 participants |
| Sex: Female, Male Female | 12 Participants | 75 Participants | 87 Participants |
| Sex: Female, Male Male | 25 Participants | 150 Participants | 175 Participants |
| Symptomatic [1] Asymptomatic | 29 participants | 191 participants | 220 participants |
| Symptomatic [1] Symptomatic | 8 participants | 34 participants | 42 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 37 | 132 / 225 |
| serious Total, serious adverse events | 11 / 37 | 37 / 225 |
Outcome results
Primary
Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure.
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MO.MA Training Cases (Roll-In) | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Stroke | 0 participants |
| MO.MA Training Cases (Roll-In) | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Death | 0 participants |
| MO.MA Training Cases (Roll-In) | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Any MACCE during the procedure | 0 participants |
| MO.MA Training Cases (Roll-In) | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Any myocardial infarction | 0 participants |
| MO.MA Training Cases (Roll-In) | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Any MACCE at discharge | 0 participants |
| MO.MA Training Cases (Roll-In) | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Any MACCE during 30 days after the procedure | 0 participants |
| MO.MA Pivotal Subjects | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Any MACCE at discharge | 4 participants |
| MO.MA Pivotal Subjects | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Any MACCE during 30 days after the procedure | 6 participants |
| MO.MA Pivotal Subjects | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Any myocardial infarction | 0 participants |
| MO.MA Pivotal Subjects | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Death | 2 participants |
| MO.MA Pivotal Subjects | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Any MACCE during the procedure | 4 participants |
| MO.MA Pivotal Subjects | Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | Stroke | 5 participants |
Comparison: The ARMOUR trial tested the null hypothesis that the MACCE rate was greater than or equal to the Performance Goal (PG) of 13% versus the alternative hypothesis that the true MACCE rate was less than the PG. The sample size was calculated based on 90% power and a Type I error rate of 0.05 (one-sided). The Performance Goal was calculated from results of carotid artery stenting trials that utilized embolic protection devices (EPD).p-value: <0.05t-test, 1 sided
Secondary
Access Site Adverse Events
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.
Time frame: Index Procedure through Hospital Discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MO.MA Training Cases (Roll-In) | Access Site Adverse Events | 2 participants |
| MO.MA Pivotal Subjects | Access Site Adverse Events | 7 participants |
Secondary
Device Success
Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MO.MA Training Cases (Roll-In) | Device Success | 37 participants |
| MO.MA Pivotal Subjects | Device Success | 221 participants |
Secondary
Procedural Success
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.
Time frame: The entire duration of the index procedure through hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MO.MA Training Cases (Roll-In) | Procedural Success | 33 participants |
| MO.MA Pivotal Subjects | Procedural Success | 207 participants |
Secondary
Restenosis at 30 Days
Number of subjects with re-narrowing of the lesion at 30 days as defined as a \>= 50% stenosis measured by duplex ultrasound scan.
Time frame: Up to 30 days after the procedure was performed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MO.MA Training Cases (Roll-In) | Restenosis at 30 Days | 2 participants |
| MO.MA Pivotal Subjects | Restenosis at 30 Days | 3 participants |
Secondary
Target Lesion Revascularization at 30 Days
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.
Time frame: Up to 30 days after the procedure was performed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MO.MA Training Cases (Roll-In) | Target Lesion Revascularization at 30 Days | 0 participants |
| MO.MA Pivotal Subjects | Target Lesion Revascularization at 30 Days | 0 participants |
Secondary
Technical Success
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MO.MA Training Cases (Roll-In) | Technical Success | 34 participants |
| MO.MA Pivotal Subjects | Technical Success | 210 participants |