Stenting for Ischemic Strokes Secondary to Medically Refractory Intracranial Atherosclerotic Disease: STRICT-ICAS
Conditions: ICAD - Intracranial Atherosclerotic Disease, Ischemic Stroke
Sponsor: Nitin Goyal

StenTing foR ischemic strokes secondary to medIcally refraCTory IntraCranial 
atherosclerotic diSease: STRICT-ICAS 
 
 
January 03, 2025 
 
 
Nitin Goyal, MD, Violiza Inoa, MD 
 
 
NCT06790147 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Title: StenTing foR ischemic strokes secondary to medIcally refraCTory IntraCranial 
atherosclerotic diSease: STRICT-ICAS 
 
Principal Investigators: Nitin Goyal, MD; Violiza Inoa, MD 
 
Institute Name and Address: 
Semmes Murphey Foundation 
6325 Humphreys Blvd, Memphis, TN 38120 
 
Collaborators: up to 10 centers.  
 
Background and Rationale 
Intracranial atherosclerotic disease (ICAD) accounts for approximately 10% of ischemic strokes 
in the United States and is a major cause of recurrent strokes. Although three randomized 
controlled trials (RCT) have failed to show the benefit of endovascular treatment [1-3], there exists 
a subset of patients who experience recurrent strokes despite maximum medical therapy. These 
patients may benefit from Percutaneous Angioplasty and Stenting (PTAS), especially when 
selecting flow-related stroke subtypes rather than perforator or embolic strokes or patients with 
recurrent transient ischemic attacks. A follow-up post-market surveillance study mandated by the 
FDA to evaluate peri-procedural safety of the Wingspan Stent (Stryker, Kalamazoo, MI) 
demonstrated reduced perioperative stroke and death rates, further suggesting that patients could 
benefit from PTAS.[4] The experience of neurointerventionalists and proper patient selection were 
the main reported factors for a lower periprocedural stroke and death rate in the WEAVE trial in 
comparison to the SAMMPRIS trial. 
 
The practice pattern of endovascular treatment for medically refractory ICAD has been evolving 
since the publication of the WEAVE trial with an increasing off-label utilization of balloon-mounted 
coronary stents or other self-expanding stents. Since the publication of the three negative RCTs, 
there has been a lack of prospective data regarding current endovascular practice patterns for 
ICAD. There is likely variation in patient selection, timing of intervention, and devices used. 
Analyzing these may provide insight into optimal practices for the endovascular treatment of ICAD 
and the design of future trials. 
 

Study Purpose: Establish a prospective multicenter registry of the patients undergoing 
intracranial stenting for ischemic strokes caused by medically refractory ICAD to evaluate current 
practice pattern, periprocedural and delayed outcomes.   
 
Study Design: Prospective, multicenter, single arm, observational study 
 
Study Population: Consecutive patients with ischemic strokes caused by medically refractory 
ICAD undergoing intracranial stenting, and meeting study inclusion criteria will be included.   
 
Study Intervention/Product and its Intended Use: Participating centers will follow their 
standard of care protocols for intracranial stenting for medically refractory ICAD. We will not 
advertise use of any specific on-label or off-label device for intracranial stenting. No new products 
will be studied or promoted.  
 
Study Duration: 2 years 
 
Inclusion Criteria (adopted from [4]) 
• 
Adult patients with ICAD resulting in 70-99% vessel stenosis who undergo PTAS with 
any device will be included.  
• 
Patients will have to experience a stroke despite medical management involving risk 
factor modification and an antiplatelet agent.  
• 
Baseline modified Rankin Scale (mRS) ≤ 3  
• 
Performance of the endovascular procedure at least 3 days after the last stroke. 
 
Exclusion Criteria:  
• 
Large vessel occlusion strokes undergoing rescue intracranial stenting will not be 
included 
• 
Baseline modified Rankin Scale (mRS) >3 
• 
Performance of the endovascular procedure less than 3 days after the last stroke. 
• 
Patients undergoing intracranial stenting for first stroke caused by ICAD  
• 
Adult patients with ICAD resulting in <70% vessel stenosis  
 
Objectives and Endpoint:  

Aim 1: To establish a prospective multicenter registry evaluating current endovascular 
practice patterns of patients undergoing PTAS for medically refractory ICAD. 
Hypothesis 1: A variety of devices besides the Wingspan stent system (Stryker 
Neurovascular, Fremont, CA, USA) will be used for PTAS, including off label use of 
coronary balloon-mounted stents or Neuroform atlas stents  
 
Aim 2: To establish a prospective multicenter registry evaluating current periprocedural 
and delayed outcomes for PTAS in patients with medically refractory ICAD. 
 
Hypothesis 2a: The periprocedural stroke, bleed, and death rate will be similar to that 
published in the WEAVE trial.[4] 
 
Hypothesis 2b: The 1-year follow-up rates of stroke within the target artery territory, 
non-traumatic hemorrhage, or neurologic death will be similar to that published in the 
WOVEN trial.[5] 
 
Outcomes:  
 
 
The primary outcomes will include:  
1. Recurrent ischemic stroke within the territory treated, intracranial hemorrhage, or death 
within 72 hours after the procedure. All of the patients enrolled in the trial will be 
assessed at 72 hours post-stenting either in the hospital by the study interventionalist or, 
if the patient had already been discharged home, by telephone interview by a core study 
nurse or interventionalist 
 
2. Stroke within the territory treated, intracranial hemorrhage, or neurologic death within 6 
months to 1 year after PTAS. All the patient enrolled in the trial will undergo 
- Follow up clinic visit between 6 months to 1 year per standard of care 
- Follow up vascular imaging (modality of imaging will be decided based 
on standard of care at participating centers) 
 
3. Secondary outcomes will include- 
• 
Stent patency on follow up vascular imaging 
• 
Re-stenosis ≥ 70% on follow up vascular imaging 

• 
mRS between days 180-360 after the procedure 
• 
Any death within 1 year after the procedure 
• 
Myocardial infarction within 72 hours after the procedure. 
 
 
Variables collected 
 
Age, sex, race, comorbidities (hypertension, hyperlipidemia, diabetes, coronary artery 
disease), smoking status, baseline mRS, affected artery, number of prior strokes attributable to 
target lesion, type of stroke (embolic, borderzone, perforator, etc.), degree of stenosis of target 
lesion, Mori classification, medical management for ICAD, type of antiplatelets, P2Y12 test 
value, aortic arch type, proximal tortuosity, collaterals, device used for PTAS, plaque anatomy, 
diameter of proximal and distal vessels, type of anesthesia, intraprocedural blood pressure, use 
of anticoagulation or IV antiplatelet therapy intraprocedurally, clinical status at 72 hours, 
periprocedural antiplatelet regimen, intraprocedural and post procedural complications, degree 
of residual stenosis, follow up vascular imaging data between 6-12 months post procedure, 
follow up clinical data between 6-12months post procedure.  
 
Sample Size: 150 patients 
 
Safety Considerations and Adverse Event Reporting: Will be done according to standard of 
care at participating centers 
 
Ethics and Regulatory Consideration: IRB approval will be taken at all participating centers. 
We will encourage centers to request waiver of informed consent process as we will be 
obtaining deidentified data regarding current practice pattern by following standard of care at 
participating centers.  
 
Data Management: Participating centers will provide data through REDCap. Study coordinator 
at Semmes Murphey Foundation will manage the REDCap database and keep it secured with 
access only to principal investigators and key study personnel.  
 
Publication Plan: JAMA or JAMA Neurology. Sequence of co-authorship will be decided based 
on level of contribution from participating centers. Will aim for 2 co-authors from each center. 
 

Imaging Core Lab: New England Imaging Core Lab 
 
Bibliography:  
 
1. Gao P, Wang T, Wang D, Liebeskind DS, Shi H, Li T, et al. Effect of Stenting Plus Medical 
Therapy vs Medical Therapy Alone on Risk of Stroke and Death in Patients With Symptomatic 
Intracranial Stenosis: The CASSISS Randomized Clinical Trial. JAMA. 2022;328(6):534-42. doi: 
10.1001/jama.2022.12000. 
2. Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, et al. Aggressive 
medical treatment with or without stenting in high-risk patients with intracranial artery stenosis 
(SAMMPRIS): the final results of a randomised trial. Lancet. 2014;383(9914):333-41. doi: 
10.1016/S0140-6736(13)62038-3. 
3. Zaidat OO, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, et al. 
Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients 
with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA. 
2015;313(12):1240-8. doi: 10.1001/jama.2015.1693. 
4. Alexander MJ, Zauner A, Chaloupka JC, Baxter B, Callison RC, Gupta R, et al. WEAVE Trial: 
Final Results in 152 On-Label Patients. Stroke. 2019;50(4):889-94. doi: 
10.1161/STROKEAHA.118.023996. 
5. Alexander MJ, Zauner A, Gupta R, Alshekhlee A, Fraser JF, Toth G, et al. The WOVEN trial: 
Wingspan One-year Vascular Events and Neurologic Outcomes. J Neurointerv Surg. 
2021;13(4):307-10. doi: 10.1136/neurintsurg-2020-016208.