Treatment Trials

4 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures
Description

This is a study to evaluate the safety and effectiveness of the Acolyte Catheter System used in CTO-PCI procedures. The system will be used for the placement and positioning of guidewires and catheters in the coronary vasculature for the treatment of patients with coronary chronic total occlusions with persistent symptoms following medical therapy.

COMPLETED
The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure
Description

Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure following both diagnostic and interventional procedures as assessed by clinical and imaging criteria.

COMPLETED
Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
Description

The purpose of this research study is to evaluate the safety and feasibility of the Impella 2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia in the setting of Ventricular dysfunction.

COMPLETED
Comparison Of Effective Radiation Shielding Between Rampart IC, M1128 Shield vs Conventional Apron And Shields In Clinical Interventional Procedures
Description

Previous studies have documented that orthopedic injuries and musculoskeletal pain are a likely result of wearing heavy leaded aprons. This single-center, randomized 1-3 month clinical study compares conventional lead aprons and ancillary shields to the Rampart IC, M1128 radiation protection system in order to improve radiation safety with minimal orthopedic strain by using the RAMPART device. There will be three study arms, each arm requiring 21 procedures for a total of 63 total procedures, Each procedure will be randomized, instead of individual subjects. Each enrolled subject may be involved in more than one procedure/case. Randomization stratification will be 1:1:1 to either Rampart shield only, lead apron and ancillary shield, or lead apron and Rampart Shield. Real-time dosimeters will be used in each procedure to measure radiation attenuation.