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Clinical Trial Summary

Recent prospective observational data has established that distal blood flow compromise measured using noninvasive quantitative magnetic resonance angiography (QMRA) identifies a high risk subgroup of patients with symptomatic atherosclerotic vertebrobasilar (VB) steno-occlusive disease, serving as an imaging biomarker for future stroke risk. The currently proposed study aims to determine if an endovascular intervention, submaximal balloon angioplasty, can be performed with adequate safety in this high risk subgroup of flow-compromised patients with VB stenosis. The study will also examine as secondary aims, the effect of the intervention on distal flow augmentation and on subsequent posterior circulation ischemic events.

Clinical Trial Description

The objective is to conduct a multicenter safety study of submaximal balloon angioplasty and intensive medical management in patients with symptomatic VB stenosis associated with distal flow compromise as demonstrated by QMRA. These objectives will be met by enrolling patients into a single arm design of angioplasty and intensive medical therapy.

Primary Objective

1. Determine the safety of submaximal balloon angioplasty for treatment of symptomatic intracranial vertebrobasilar stenosis with distal flow compromise (device safety)

Secondary Objectives

1. A. Evaluate the initial hemodynamic effect of submaximal balloon angioplasty for symptomatic intracranial vertebrobasilar stenosis with distal flow compromise (evidence of short term biomarker modification) B. Evaluate the hemodynamic durability of submaximal balloon angioplasty at one year (evidence of sustained biomarker modification)

2. Estimate the risk of subsequent posterior circulation stroke (at one year) following submaximal balloon angioplasty for distal flow compromised symptomatic intracranial vertebrobasilar stenosis (preliminary clinical efficacy) ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03729817
Study type Interventional
Source University of Illinois at Chicago
Status Not yet recruiting
Phase N/A
Start date May 2019
Completion date April 2024

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