EXCEL-II Stent Vesus EXCEL Stent to Treat the Patients With de Novo

Status Completed

Clinical Trial Summary

The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.

Clinical Trial Description

The primary end point is to observe in-stent late lumenn loss after 9 months of the stent implantation. This study is based on non-inferior assumption (vs. EXCEL-II V EXCEL Stent), requring all of end points reach statictic significance. Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems). Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used and normal ranges if relevant. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02057978
Study type	Observational [Patient Registry]
Source	JW Medical Systems Ltd
Contact
Status	Completed
Phase
Start date	December 8, 2013
Completion date	December 25, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

EXCEL-II Stent Vesus EXCEL Stent to Treat the Patients With de Novo Coronary Artery Lesions. — CREDIT-II

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms