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

NCT03729817 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-11-04

No results posted yet for this study

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

Interventions

DEVICE

Submaximal balloon angioplasty

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.

Sponsors & Collaborators

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Sepideh Amin-Hanjani, MD · Case Western Reserve University

  • Adnan Siddiqui, MD · University at Buffalo

  • Tanya Turan, MD · Medical University of South Carolina

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-10-31
Primary Completion
2031-10-31
Completion
2032-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729817 on ClinicalTrials.gov