Trial Outcomes & Findings for Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (NCT NCT00576693)

Last Updated: 2018-05-30

Results Overview

Any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days after enrollment OR any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days of any revascularization procedure of the qualifying symptomatic intracranial artery done during follow-up, OR an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow-up.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

451 participants

Primary outcome timeframe

Mean length of follow-up was 2.4 years

Results posted on

2018-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Intensive Medical Management Plus Stenting intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl). intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia	Intensive Medical Management Alone Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl) intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl)
Overall Study STARTED	224	227
Overall Study COMPLETED	214	203
Overall Study NOT COMPLETED	10	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Intensive Medical Management Plus Stenting intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl). intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia	Intensive Medical Management Alone Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl) intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl)
Overall Study Lost to Follow-up	7	11
Overall Study Withdrawal by Subject	3	13

Baseline Characteristics

Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive Medical Management Plus Stenting n=224 Participants intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl). intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia	Intensive Medical Management Alone n=227 Participants Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl) intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl)	Total n=451 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 10.7 • n=5 Participants	59.5 years STANDARD_DEVIATION 11.8 • n=7 Participants	60.2 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	82 Participants n=7 Participants	179 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	145 Participants n=7 Participants	272 Participants n=5 Participants
Race/Ethnicity, Customized Black	55 participants n=5 Participants	49 participants n=7 Participants	104 participants n=5 Participants
Race/Ethnicity, Customized White	160 participants n=5 Participants	162 participants n=7 Participants	322 participants n=5 Participants
Race/Ethnicity, Customized Other	9 participants n=5 Participants	16 participants n=7 Participants	25 participants n=5 Participants
History of Hypertension Yes	200 participants n=5 Participants	203 participants n=7 Participants	403 participants n=5 Participants
History of Hypertension No	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
History of Lipid Disorder Yes	195 participants n=5 Participants	202 participants n=7 Participants	397 participants n=5 Participants
History of Lipid Disorder No	29 participants n=5 Participants	25 participants n=7 Participants	54 participants n=5 Participants
Smoking Never	90 participants n=5 Participants	78 participants n=7 Participants	168 participants n=5 Participants
Smoking Previously	79 participants n=5 Participants	80 participants n=7 Participants	159 participants n=5 Participants
Smoking Currently	54 participants n=5 Participants	69 participants n=7 Participants	123 participants n=5 Participants
Diabetes Yes	105 participants n=5 Participants	103 participants n=7 Participants	208 participants n=5 Participants
Diabetes No	119 participants n=5 Participants	124 participants n=7 Participants	243 participants n=5 Participants
Systolic Blood Pressure	143.9 mmHg STANDARD_DEVIATION 20.6 • n=5 Participants	146.8 mmHg STANDARD_DEVIATION 21.8 • n=7 Participants	145.4 mmHg STANDARD_DEVIATION 21.3 • n=5 Participants
Low Density Lipoprotein Cholesterol	96.2 mg/dl STANDARD_DEVIATION 38.4 • n=5 Participants	97.7 mg/dl STANDARD_DEVIATION 36.6 • n=7 Participants	97.0 mg/dl STANDARD_DEVIATION 37.5 • n=5 Participants
Body Mass Index	30.3 kg/m^2 STANDARD_DEVIATION 6.2 • n=5 Participants	30.7 kg/m^2 STANDARD_DEVIATION 6.3 • n=7 Participants	30.5 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants
History of Coronary Artery Disease Yes	47 participants n=5 Participants	59 participants n=7 Participants	106 participants n=5 Participants
History of Coronary Artery Disease No	177 participants n=5 Participants	168 participants n=7 Participants	345 participants n=5 Participants
History of Stroke (Not Qualifying Event) Yes	60 participants n=5 Participants	58 participants n=7 Participants	118 participants n=5 Participants
History of Stroke (Not Qualifying Event) No	164 participants n=5 Participants	169 participants n=7 Participants	333 participants n=5 Participants
Qualifying Event Stroke	142 participants n=5 Participants	152 participants n=7 Participants	294 participants n=5 Participants
Qualifying Event TIA	82 participants n=5 Participants	75 participants n=7 Participants	157 participants n=5 Participants
On Antithrombotic Therapy at Qualifying Event Yes	144 participants n=5 Participants	140 participants n=7 Participants	284 participants n=5 Participants
On Antithrombotic Therapy at Qualifying Event No	80 participants n=5 Participants	87 participants n=7 Participants	167 participants n=5 Participants
Time from Qualifying Event to Randomization	7 days n=5 Participants	7 days n=7 Participants	7 days n=5 Participants
Symptomatic Qualifying Artery Internal Carotid Artery	45 participants n=5 Participants	49 participants n=7 Participants	94 participants n=5 Participants
Symptomatic Qualifying Artery Middle Cerebral Artery	92 participants n=5 Participants	105 participants n=7 Participants	197 participants n=5 Participants
Symptomatic Qualifying Artery Vertebral Artery	38 participants n=5 Participants	22 participants n=7 Participants	60 participants n=5 Participants
Symptomatic Qualifying Artery Basilar Artery	49 participants n=5 Participants	51 participants n=7 Participants	100 participants n=5 Participants
Percent Stenosis of Symptomatic Qualifying Artery	80 % of the diameter the artery STANDARD_DEVIATION 7 • n=5 Participants	81 % of the diameter the artery STANDARD_DEVIATION 7 • n=7 Participants	81 % of the diameter the artery STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: Mean length of follow-up was 2.4 years

Population: All patients enrolled in the study were included in the primary outcome analysis.

Outcome measures

Outcome measures
Measure	Intensive Medical Management Plus Stenting n=224 Participants intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl). intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia	Intensive Medical Management Alone n=227 Participants Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl) intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl)
Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment.	52 participants	34 participants

Adverse Events

Intensive Medical Management Plus Stenting

Serious events: 146 serious events

Other events: 117 other events

Deaths: 0 deaths

Intensive Medical Management Alone

Serious events: 121 serious events

Other events: 118 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Intensive Medical Management Plus Stenting n=224 participants at risk intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl). intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia	Intensive Medical Management Alone n=227 participants at risk Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl) intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl)
Nervous system disorders Transient Ischemic Attack / Cerebral Infarct with Temporary Signs	12.1% 27/224 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.	15.0% 34/227 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
General disorders Systemic Hemorrhage	12.9% 29/224 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.	10.6% 24/227 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Cardiac disorders Cardiac General	17.4% 39/224 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.	15.4% 35/227 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Gastrointestinal disorders Gastrointestinal	2.2% 5/224 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.	6.6% 15/227 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Metabolism and nutrition disorders Metabolic / Laboratory	7.6% 17/224 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.	5.7% 13/227 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Musculoskeletal and connective tissue disorders Musculoskeletal / Soft Tissue	9.4% 21/224 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.	4.0% 9/227 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Nervous system disorders Neurology	11.2% 25/224 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.	11.0% 25/227 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
General disorders Pain	6.2% 14/224 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.	4.8% 11/227 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Respiratory, thoracic and mediastinal disorders Pulmonary / Upper Respiratory	5.4% 12/224 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.	4.4% 10/227 • Mean length of follow-up was 2.4 years The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.

Additional Information

Marc I. Chimowitz, MBChB

Medical University of South Carolina

Phone: 843-792-3020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place