Treatment Trials

15 Clinical Trials for Various Conditions

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COMPLETED
A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
Description

LASN01 is a novel, fully human antibody directed against the human IL-11 receptor being developed for treatment of patients with thyroid eye disease (TED). The primary and secondary objectives of this study are to evaluate the safety, treatment effect, and pharmacokinetics of LASN01 administered IV in patients with TED with no prior anti-IGF-1R treatment or in patients with TED who have previously received teprotumumab treatment.

RECRUITING
A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Description

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.

ACTIVE_NOT_RECRUITING
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Description

The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).

COMPLETED
Rituximab in the Treatment of Scleritis and Non-Infectious Orbital Inflammation
Description

The purpose of this study is to assess the safety and tolerability of Rituximab in refractory scleritis and non-infectious orbital inflammation.

COMPLETED
Evaluation of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease
Description

To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.

COMPLETED
Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)
Description

This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel patency following treatment. Safety will be assessed by monitoring adverse events throughout the study. Safety and Efficacy will be evaluated by comparing study results to established performance criteria,

COMPLETED
Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound
Description

This single center prospective, randomized study will be conducted to investigate plaque removal and luminal gain using CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy System (OAS) (St.Paul, MN) versus Medtronic's Hawkone Directional Atherectomy system (DAS) (Minneapolis, MN) assessed by angiography and Intravascular Ultrasound (IVUS) in patients diagnosed with symptomatic obstructive femoro-popliteal disease will be analyzed. Both devices have received clearance by the Food and Drug Administration (FDA) for use by the label indication.Subjects will be randomized in a 1:1 fashion to receive treatment with either OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) or DAS (using the Hawkone device) followed by DCB. Subjects in both arms will undergo IVUS before and after atherectomy, as well as at the conclusion of the procedure. Clinical data will be collected at baseline, immediately prior to the procedure, during and immediately after the procedures, and within 30 days, 6 and 12 months office visits after the procedure. Data may also be collected at office or hospital visits that are not scheduled but occur up to 12 months after the procedure, if they pertain to treatment related to the obstructive SFA disease. Data to be collected for this study includes demographics, medical history, procedural parameters and follow-up. The study will be conducted at one study center, 90 subjects will be enrolled in the trial with plan to accrue 60 subjects - 30 patients enrolled in the OAS arm and 30 patients enrolled in the DAS arm. The duration of the study is expected to be approximately 2 years from the date of first enrollment (1 year for enrollment of 60 subjects and a year for follow-up).

ACTIVE_NOT_RECRUITING
Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial
Description

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

COMPLETED
Feasibility of Orbital Atherectomy System in Calcified Bifurcation Lesion
Description

ORBID-OA is a single-center, observational study in 30 patients with stable coronary artery disease. The aim of the study is to analyze the outcomes of main vessel stenting on side branch in calcified bifurcation lesion and identify preprocedural predictors of side branch complication by utilizing two-dimensional (2D) and three-dimensional (3D) frequency domain optical coherence tomography (FD-OCT).

COMPLETED
Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in PCI
Description

The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation atherectomy device, reduces the incidence of microcirculatory compromise as compared to older generation rotational atherectomy (RA) due to differences in the mechanism of athero-ablation.

COMPLETED
Coronary Flow Reserve Following Orbital Atherectomy
Description

The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.

COMPLETED
Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy
Description

OBJECTIVES: I. Evaluate the effects of 20 Gy of external-beam radiotherapy to 1 orbit vs. the untreated orbit at 3 and 6 months after therapy in patients with Graves' ophthalmopathy. II. Evaluate whether 20 Gy of external-beam radiotherapy delivered to the second orbit 6 months later in the course of the disease produces effects of equal magnitude to those observed when the first orbit was treated. III. Relate the magnitude of treatment effects to the time since onset of eye symptoms. IV. Evaluate whether characteristics of radiation retinopathy are present 3 years after orbital radiotherapy.

Conditions
COMPLETED
Complete Lesion Assessment With ffR and IVUS TechnologY
Description

CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).

COMPLETED
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal
Description

IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).

COMPLETED
Brain Changes in Children and Adolescents With Behavioral Problems
Description

Purpose: This study will examine brain activity in children age 10-18 with disruptive behavior problems, including conduct disorder (CD), oppositional defiant disorder (ODD), and attention deficit hyperactivity disorder (ADHD), compared with children without behavioral problems. Our goal is to examine differences in how emotions, social situations, and problem-solving situations are processed in the brain across these groups of children.