Clinical Trials Logo

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
Contact
Status Not yet recruiting
Phase N/A
Start date May 2019
Completion date April 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Active, not recruiting NCT03698357 - Video Balance-based Exercise in Persons With Stroke N/A
Recruiting NCT03402906 - Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke N/A
Completed NCT03575481 - Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke
Recruiting NCT03542188 - TReatment Strategy In Acute Ischemic larGE Vessel STROKE: Prioritize Thrombolysis or Endovascular Treatment N/A
Recruiting NCT03305731 - Activating Behavior for Lasting Engagement After Stroke N/A
Recruiting NCT02822144 - General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke Phase 3
Active, not recruiting NCT03371290 - Acute Effect of Mirror Therapy on Rehabilitation of Paretic Upper Extremity After Chronic Stroke N/A
Recruiting NCT03294187 - Encouragement-induced Movement Therapy in Daily Life N/A
Enrolling by invitation NCT03259373 - IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation N/A
Recruiting NCT01996137 - VASSTII: An Exploratory Clinical Study on a VASST IITreadmill System for Post Stroke Gait Rehabilitation. N/A
Completed NCT03559829 - Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke N/A
Enrolling by invitation NCT03314818 - Natural History of Carotid Plaque as Determined by 3D Ultrasound N/A
Recruiting NCT03236376 - Brain-behavior Associations of Sensorimotor Therapy Post Stroke N/A
Recruiting NCT02911129 - Effects of Prism Adaption and rTMS on Brain Connectivity and Visual Representation