REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis

NCT03729817 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2023
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

By assessing the safety and durability of an endovascular intervention, this study will justify and inform the design of a subsequent seamless feasibility/pivotal trial aimed at the treatment of intracranial atherosclerotic stenosis (ICAS), an entity which carries a high risk of stroke despite existing medical therapies, and has no other treatment options. Given the global burden of ICAS as a leading cause of stroke, there is a high potential for public health impact not just in the U.S., but world-wide.

Conditions

Intracranial Atherosclerotic Disease; Stroke; Angioplasty, Balloon; Hemodynamics; Device Safety

Keywords

Intracranial atherosclerotic disease; Stroke; Angioplasty, Balloon; Hemodynamics; Device Safety

Outcome Measures

Primary Outcomes (1)

• Procedural Safety

  Any stroke (ischemic or hemorrhagic), or death, within 30 days following submaximal angioplasty

  30 days

Secondary Outcomes (3)

• Clinical Efficacy

  1 year

• Hemodynamic Success

  post procedure (within 7 days)

• Hemodynamic Durability

  1 year

Study Arms (1)

Submaximal balloon angioplasty plus intensive medical therapy

EXPERIMENTAL

Endovascular intervention with submaximal balloon angioplasty

Device: Submaximal balloon angioplasty

Interventions

Submaximal balloon angioplasty DEVICE

An endovascular procedure involving inflation of a balloon catheter undersized to 50-75% of normal vessel diameter to perform angioplasty of a stenotic blood vessel segment, with the goal of increasing blood flow.

Submaximal balloon angioplasty plus intensive medical therapy

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-severe recent stroke (within 30 days) attributed to 70-99% stenosis of intracranial artery (internal carotid, middle cerebral, vertebral, basilar); must be confirmed by CTA (or DSA if already available) for enrollment into the trial.
• Hemodynamic compromise based on borderzone infarct pattern\* for the anterior circulation (internal carotid and middle cerebral artery stenosis) and by low flow state on QMRA\*\* for the posterior circulation (vertebral and basilar artery stenosis).
• Target vessel with minimal nominal diameter of 2mm
• Target length of stenosis \<18mm
• Symptoms within 30 days of enrollment
• Age ≥30 and ≤90 years old#
• Able to provide informed consent
• \*Sole or predominant borderzone infarct pattern of qualifying event, as defined by SAMMPRIS cohort analysis \*\*Low flow state as determined by optimized flow algorithm as defined by the VERiTAS Study
• #Those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years).

You may not qualify if:

• Major disabling stroke mRS \>3; progressive or fluctuating deficit within 24 hours
• Hemorrhagic infarction (based on CT) within 14 days of enrollment
• Any large stroke (\>5cm) to be at risk for hemorrhagic conversion
• Any neurological disease which would confound follow-up assessment
• Any co-morbid disease condition with \<12 month life expectancy
• Known cardiac disease associated with elevated cardioembolic risk, specifically, atrial fibrillation, prosthetic valve, endocarditis, left atrial/ventricular thrombus, cardiomyopathy with EF\<25%, cardiac myxoma
• Blood dyscrasias, specifically polycythemia vera, essential thrombocytosis, sickle cell disease
• Active bleeding diathesis, h/o major systemic hemorrhage within 30 days, active PUD, platelets\<100K (severe liver impairment (AST or ALT\>3 x normal, cirrhosis)
• Non-atherosclerotic stenosis including dissection, fibromuscular dysplasia, vasculitis, radiation induced vasculopathy, suspected recanalized embolus, suspected vasospastic process
• Mori C classification of stenosis (i.e. diffuse lesion, extremely angulated \>90⁰, excessive proximal tortuosity) Previous treatment of target lesion with stent, angioplasty or other mechanical device
• Unable or unwilling to undergo MRI
• Unable to undergo cerebral angiography
• Pregnancy
• Concurrent participation in another study which would conflict with the current study
• Allergy or contraindication to aspirin or Plavix

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sepideh Amin-Hanjani, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Adnan Siddiqui, MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Tanya Turan, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sepideh Amin-Hanjani, MD

CONTACT

216 286-8945; Sepideh.Hanjani@Uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice-Chair Department of Neurosurgery, Case Western Reserve University

Model Details: Subjects will be recruited into a prospective single-arm multi-center pilot study to assess the safety of submaximal balloon angioplasty in conjunction with intensive medical therapy in patients with hemodynamically-compromised symptomatic 70-99% atherosclerotic intracranial stenosis (ICAS).

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 5, 2018
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): October 31, 2031
• Study Completion (Estimated): October 31, 2032
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)