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

Yonsei University

Status and phase: Withdrawn; Phase 4

Conditions: Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCI

Treatments: Device: DESyne drug-eluting stents implantation; Device: Cilotax drug-eluting stents implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02060175

1-2013-0076

Details and patient eligibility

About

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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1 CILOTAX arm

Experimental group

Description:

Cilotax drug-eluting stents implantation

Treatment:

Device: Cilotax drug-eluting stents implantation

2 DESyne arm

Active Comparator group

Description:

DESyne drug-eluting stents implantation

Treatment:

Device: DESyne drug-eluting stents implantation