Clinical Trials

Capsular REpair randomiSed controlled Trial (CREST) is a multi-center, randomized controlled trial with a sample size of 240 patients (120 patients in each group). The primary outcome measure is functional outcome as measured by the change in Hip Outcome Score at 6 months with secondary outcomes being hip range of motion, i-HOT 12, overall satisfaction, and VAS. Patients are stratified based on gender. Patients, outcome assessors, and data analysts are blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics.

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

The purpose of this study is to compare the relatively new procedure of stent-assisted carotid angioplasty to the traditional and accepted surgical approach of carotid endarterectomy for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).

The purpose of this study is a long-term observational extension of the CREST-2 trial (C2LOE) to describe the comparative treatment effectiveness over a longer period of expected benefit from revascularization than can be accomplished in the parent trial alone. CREST-2 is a multicenter randomized trial of intensive medical management (IMM) with or without revascularization in patients with asymptomatic high-grade carotid stenosis (ClinicalTrials.gov Identifier: NCT02089217).

The purpose of this study is to compare the post-procedure treatment differences in stroke risk between those randomized to revascularization and intensive medical management (IMM) and those randomized to IMM alone.

The purpose of this Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial study is to assess post-procedural efficiency of carotid endarterectomy and carotid stenting.

The primary specific aim of the study is to compare the post-procedure treatment differences in stroke risk between those randomized to revascularization and intensive medical management (IMM) and those randomized to IMM alone. This difference will be assessed using proportional hazards analysis, with the primary analysis restricted to those who are stroke-free at the end of the 44-day periprocedural period and with the primary analysis being performed on the intention-to-treat population.

We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired subset of the CREST-2 -randomized patients. We will enroll 500 patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly thereafter. We anticipate identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI perfusion "time to peak" (TTP) delay on the side of stenosis. Among those who are found to be hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at baseline and at 1 year will determine if those with flow failure who are randomized to a revascularization arm in CREST-2 will have better cognitive outcomes than those in the medical-only arm compared with this treatment difference for those who have no flow failure. We hypothesize that hemodynamically significant "asymptomatic" carotid disease may represent one of the few examples of treatable causes of cognitive impairment. If cognitive decline can be reversed in these patients, then we will have established a new indication for carotid revascularization independent of the risk of recurrent stroke.

The purpose of this study is to assess whether our not the percentage of pulmonary related vascular structures (PRVS) determined by the quantitative CT (Q-CT) tool CALIPER is a novel measure that can be used for the early detection of pulmonary vascular remodeling in patients with SSc.  pulmonary related vascular structures