Stenting for Ischemic Strokes Secondary to Medically Refractory Intracranial Atherosclerotic Disease

NCT06790147 | Not Yet Recruiting

• 1 other identifier: ERP-2024-13724
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to establish a prospective multicenter registry of patients undergoing intracranial stenting for ischemic strokes caused by medically refractory ICAD. The study aims to evaluate current practice patterns, periprocedural outcomes, and delayed outcomes. Researchers will collect demographic and procedural data from patients who undergo intracranial stenting after having an ischemic stroke caused by medically refractory ICAD.

Conditions

ICAD - Intracranial Atherosclerotic Disease; Ischemic Stroke

Keywords

ICAD; ischemic stroke; prospective registry

Outcome Measures

Primary Outcomes (2)

• Recurrent ischemic stroke within treated territory, ICH, or death

  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.

  72 hours post procedure

• Stroke, ICH, or neurological death in treated territory

  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)

  6 months to 1 year post procedure

Secondary Outcomes (5)

• Stent patency

  6 months to 1 year post procedure

• Re-stenosis ≥ 70%

  6 months to 1 year post procedure

• mRS

  6 months to 1 year post procedure

• Mortality

  1 year post procedure

• Myocardial infarction

  72 hours post procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes consecutive patients with ischemic strokes caused by medically refractory ICAD undergoing intracranial stenting.

You may qualify if:

• Adult patients with ICAD resulting in 70-99% vessel stenosis who undergo PTAS with any device
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nitin Goyal: lead
• Medtronic: collaborator

Study Sites (1)

Semmes Murphey Clinic

Memphis, Tennessee, 38120, United States

Location

Related Publications (5)

• Alexander MJ, Zauner A, Gupta R, Alshekhlee A, Fraser JF, Toth G, Given C, Mackenzie L, Kott B, Hassan AE, Shownkeen H, Baxter BW, Callison RC, Yu W. The WOVEN trial: Wingspan One-year Vascular Events and Neurologic Outcomes. J Neurointerv Surg. 2021 Apr;13(4):307-310. doi: 10.1136/neurintsurg-2020-016208. Epub 2020 Jun 19.

  PMID: 32561658 BACKGROUND

• Alexander MJ, Zauner A, Chaloupka JC, Baxter B, Callison RC, Gupta R, Song SS, Yu W; WEAVE Trial Sites and Interventionalists. WEAVE Trial: Final Results in 152 On-Label Patients. Stroke. 2019 Apr;50(4):889-894. doi: 10.1161/STROKEAHA.118.023996.

  PMID: 31125298 BACKGROUND

• Zaidat OO, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, Gupta R, Kirshner H, Megerian JT, Lesko J, Pitzer P, Ramos J, Castonguay AC, Barnwell S, Smith WS, Gress DR; VISSIT Trial Investigators. 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 Mar 24-31;313(12):1240-8. doi: 10.1001/jama.2015.1693.

  PMID: 25803346 BACKGROUND

• Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, Montgomery J, Nizam A, Lane BF, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Lynch JR, Zaidat OO, Rumboldt Z, Cloft HJ; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. 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 Jan 25;383(9914):333-41. doi: 10.1016/S0140-6736(13)62038-3. Epub 2013 Oct 26.

  PMID: 24168957 BACKGROUND

• Gao P, Wang T, Wang D, Liebeskind DS, Shi H, Li T, Zhao Z, Cai Y, Wu W, He W, Yu J, Zheng B, Wang H, Wu Y, Dmytriw AA, Krings T, Derdeyn CP, Jiao L; CASSISS Trial Investigators. 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 Aug 9;328(6):534-542. doi: 10.1001/jama.2022.12000.

  PMID: 35943472 BACKGROUND

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Study Officials

• Nitin Goyal, MD

  Semmes Murphey Clinic

  PRINCIPAL INVESTIGATOR

• Violiza Inoa, MD

  Semmes Murphey Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Goyal, MD

CONTACT

901-522-7700; ngoyal@semmes-murphey.com

Violiza Inoa, MD

CONTACT

9015227700; vinoa@semmes-murphey.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The IPD will be available following study completion in 2027 with no set end date.
• Access Criteria: A designated biostatistician will access the IPD. Access will be established through a data use agreement. Following publication, results and supporting information will be shared on the ClinicalTrials.gov website.

Locations

US (1)