NCT02057978

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

A Prospective Multicenter Randomized Trial to Assess the Safety and Effectiveness of EXCEL-II vs. EXCEL Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery Lesions .( CREDIT II Trial )

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 419 (actual)
• Sponsor: JW Medical Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia
• Coronary Disease
• Heart Diseases
• Cardiovascular Diseases
• Arteriosclerosis
• Arterial Occlusive Diseases
• Vascular Diseases

Interventions

Type	Name	Description
PROCEDURE	EXCEL DES implatation	Implant DES for CAD cases
PROCEDURE	EXCEL-II DES implantation	Implant DES for CAD cases

Timeline

• Start date: 2013-12-08
• Primary completion: 2017-10-20
• Completion: 2019-12-25
• First posted: 2014-02-07
• Last updated: 2023-04-26

Locations

1 site across 1 country: China