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BuMA OCT Study(A Comparative Evaluation of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)

NCT01752582 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-03-14

No results posted yet for this study

Summary

The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT.

This is a prospective, single center, randomized, open-label, non-inferiority study, which will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was met, superiority test will be planned.

Conditions

Interventions

DEVICE

BuMA stent

About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy.

DEVICE

EXCEL stent

About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy.

Sponsors & Collaborators

  • Sino Medical Sciences Technology Inc.

    lead INDUSTRY

Principal Investigators

  • Yang Y Jin, president · Fuwai Hospital, Chinese Academy of Medical Science

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01752582 on ClinicalTrials.gov