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Efficacy and Safety of Nano+ Polymer-free Sirolimus-Eluting Stent: A Optical Coherent Tomography Study

NCT01925027 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-12-15

No results posted yet for this study

Summary

Our hypothesis is to test that 1) The safety and efficacy of Nano+ DES in patients with de novo lesions; 2) A low neointimal hyperplasia after Nano+ DES implantation due to its effective and sufficient antiproliferative drug; 3) A very high coverage and an improved early arterial healing after Nano+ DES implantation due to polymer-free; 4) The safety of clopidogrel treatment discontinuation at 3 months when OCT results are defined as optimal.

Conditions

Interventions

DEVICE

Nano+ DES

All patients will be treated with the NanoTM Polymer-free Sirolimus Coronary Stent System. All patients will undergo angiographic (QCA) investigation at baseline (pre- and post-procedure) and at 3 months follow-up. All patients will undergo OCT investigation at 3 months follow-up. All patients will be evaluated clinically at 3, 4, 5 months (for patients with 6 months OCT follow-up evaluation will be at 8 months) and at 1 and 2 years.

Sponsors & Collaborators

  • Lepu Medical Technology (Beijing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Patrick W Serruys, PhD · Erasmus Medical Center

  • Run-Lin Gao, MD · Fu Wai Hospital, Beijing, China

  • Bo Xu, MSc · Fu Wai Hospital, Beijing, China

  • Yao-Jun Zhang, PhD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-07-31
Completion
2016-11-30

Countries

  • Belgium
  • Netherlands

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 NCT01925027 on ClinicalTrials.gov