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A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions — CREDIT  

Coronary Artery Disease Clinical Trial

Official title:
A PILOT First-In-Man Study to Evaluate Safety and Efficacy of the EXCEL-Ⅱ With Cobalt Chromium Alloys Sirolimus Eluting Biodegradable Polymer Stent in the Treatment of Patients With de Novo Coronary Artery Lesions(CREDIT-I)

Clinical Trial Summary

One of the purpose of this study is to assess the preliminary safety and feasibility,and to provide related information and evidence for the design of the further pivotal randomized control trial.the other purpose is to assess the performace of the stent delivery system.

Clinical Trial Description

1. Single-center, prospective, pilot study 2. De novo,coronary artery, single vessel and single lesion 3. Sample size = 45 4. Follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years 5. Randomization 2:1 Angio and OCT scheduled follow-up in the hospital 6. Follow-up Angio and OCT randomized 30 patients for 4-month and 15 patiens for 12-month ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01909869
Study type Interventional
Source JW Medical Systems Ltd
Contact
Status Completed
Phase N/A
Start date January 2013
Completion date June 4, 2019
View Details
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