A Phase 2/3 interventional study of Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel) and Aspirin and Clopidogrel (Medical therapy) in Ischemic Stroke and Transient Ischemic Attack, sponsored by Codman & Shurtleff. Terminated. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-02-20.
Sponsored by Codman & Shurtleff · Phase 2/3, Interventional, and Treatment
The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial.
A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.
1.1 Study Hypothesis Treatment of cerebral or retinal ischemia due to plaque in the neurovasculature using the PHAROS Vitesse Stent System plus medical therapy will provide additional clinical benefit over medical therapy alone.
1.2 Primary Effectiveness Endpoint
The primary effectiveness endpoint consists of a composite of the two following outcomes:
1.3 Safety Outcomes
Safety outcomes to be collected and reported as part of the overall risk-to-benefit profile for this device are:
1.4 Other Outcomes
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 125 is close to the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Codman & Shurtleff is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Target vessel diameter / lesion length measurements are within one of the below per angiogram:
Exclusion Criteria:
Subject has contraindications for balloon expandable stent, e.g.
CT scan or MRI evidence of any of the following:
Subject has concurrent intracranial pathology, e.g.
Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
Device: Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)
Medical therapy alone ("Medical Therapy Group")
Drug: Aspirin and Clopidogrel (Medical therapy)
Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions + Medical therapy \[Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)\]
Also known as: Pharos Vitesse Neurovascular Stent System, Asprin, Clopidogrel, Plavix(r)
Medical therapy alone \[Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)\]
Also known as: Aspirin, Clopidogrel, Plavix(r)
Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months
The primary effectiveness endpoint was a composite of the two following outcomes: * Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization * Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization A subject was deemed to be a primary endpoint success if neither of these outcomes occurred. The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months).
Time frame: One Year
Subjects were screened and enrolled at 27 sites worldwide (23 sites in the US and 4 sites outside of the US).
| Milestone | Stent Group | Medical Therapy Group |
|---|---|---|
| Started | 59 | 53 |
| Itt population (met eligibility) | 58 | 53 |
| Completed | 49 | 41 |
| Not completed | 10 | 12 |
| Withdrew: Lost to follow-up | 6 | 10 |
| Withdrew: Death | 4 | 2 |
The primary effectiveness endpoint was a composite of the two following outcomes: * Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization * Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization A subject was deemed to be a primary endpoint success if neither of these outcomes occurred. The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months).
| percent probability | Stent Group | Medical Therapy Group |
|---|---|---|
| Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months | 62.24 (48.15 to 73.15) | 83.68 (69.94 to 91.50) |
Collected over Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stent Group | — | 30/58 (51.7%) | 37/58 (63.8%) |
| Medical Therapy Group | — | 20/53 (37.7%) | 34/53 (64.2%) |
| Event | Stent Group | Medical Therapy Group |
|---|---|---|
| Ischaemic strokeNervous system disorders | 7/58 | 4/53 |
| Transient ischaemic attackVascular disorders | 2/58 | 4/53 |
| Urinary tract infectionRenal and urinary disorders | 3/58 | 1/53 |
| Atrial fibrillationCardiac disorders | 0/58 | 2/53 |
| Chest painCardiac disorders | 0/58 | 2/53 |
| Clostridium difficile colitisInfections and infestations | 0/58 | 2/53 |
| Transient ischaemic attackNervous system disorders | 0/58 | 2/53 |
| Arterial restenosisInjury, poisoning and procedural complications | 2/58 | 1/53 |
| Cerebral infarctionNervous system disorders | 2/58 | 0/53 |
| Cerebrovascular accidentNervous system disorders | 2/58 | 1/53 |
| Event | Stent Group | Medical Therapy Group |
|---|---|---|
| Transient ischaemic attackVascular disorders | 2/58 | 8/53 |
| HypertensionVascular disorders | 7/58 | 7/53 |
| FallInjury, poisoning and procedural complications | 6/58 | 4/53 |
| ConstipationGastrointestinal disorders | 5/58 | 1/53 |
| Urinary tract infectionRenal and urinary disorders | 5/58 | 1/53 |
| HeadacheNervous system disorders | 4/58 | 3/53 |
| VasospasmVascular disorders | 4/58 | 0/53 |
| AnaemiaBlood and lymphatic system disorders | 3/58 | 2/53 |
| HyperglycaemiaEndocrine disorders | 3/58 | 0/53 |
| HypokalaemiaMetabolism and nutrition disorders | 3/58 | 1/53 |
Analyses were based on an Intent-to-Treat (ITT) population, defined ad enrolled subjects who met the inclusion/exclusion criteria and who were randomized post angiogram. Stent and medical Therapy Group subjects were analyzed to their ITT randomized group regardless of treatment received.
| Age, Continuous(years) | Stent Group | Medical Therapy Group | Total |
|---|---|---|---|
| Mean | 61.8 ± 12.3 | 61.8 ± 12.8 | 61.8 ± 12.5 |
| Sex: Female, Male(Participants) | Stent Group | Medical Therapy Group | Total |
|---|---|---|---|
| Female | 17 | 21 | 38 |
| Male | 41 | 32 | 73 |
| Ethnicity (NIH/OMB)(Participants) | Stent Group | Medical Therapy Group | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 2 | 7 |
| Not Hispanic or Latino | 53 | 51 | 104 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Stent Group | Medical Therapy Group | Total |
|---|---|---|---|
| Asian | 7 | 7 | 14 |
| Native Hawaiian or Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 5 | 9 |
| White | 42 | 38 | 80 |
| Unknown or Not Reported | 5 | 3 | 8 |
| Region of Enrollment(participants) | Stent Group | Medical Therapy Group | Total |
|---|---|---|---|
| United States | 47 | 42 | 89 |
| China | 7 | 7 | 14 |
| Austria | 4 | 4 | 8 |
No study locations are listed for this record.
This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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