Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne

Phase 4

Withdrawn

• Conditions: Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCI
• Interventions: Device: DESyne drug-eluting stents implantation; Device: Cilotax drug-eluting stents implantation

• Registration Number: NCT02060175
• Lead Sponsor: Yonsei University

Brief Summary

We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between the Cilotax and DESyne drug-eluting stents (DES). The extent of the strut uncoverage has not been evaluated yet for both the Cilotax and DESyne and we first sought to decide the reference intervals using 40 samples (total 44 patients for each group considering 10% drop-out rate) as the pilot study.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-09
• Study First Posted: 2014-02-11
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients ≥ 20 years old
• Patients in the treatment of subjects with all-comer who are to undergo PCI

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Exclusion Criteria

• Pregnant women or women with potential childbearing
• Life expectancy < 1 year

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 DESyne arm	DESyne drug-eluting stents implantation	DESyne drug-eluting stents implantation
1 CILOTAX arm	Cilotax drug-eluting stents implantation	Cilotax drug-eluting stents implantation

Primary Outcome Measures

Name	Time	Method
Stent coverage	up to 3 months after stent implantation	The percentage of stent uncoverage measured by OCT