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OCT Evaluation of Healing of COMBO Stent

NCT01274234 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2013-02-28

No results posted yet for this study

Summary

All subjects requiring percutaneous coronary intervention (PCI) and stenting are eligible to participate in the study. Restudy coronary angiogram with Optical Coherence Tomography (OCT) would be performed between 1 to 5 months at the time of a staged PCI procedure (for remaining coronary disease) or as clinically indicated, and then at 9 months. At the time of the 9-month restudy (a proper time window for drug eluting stent to develop into restenosis should it occur), any new disease detected or restenosis will be treated. The reported incidence of drug eluting stent restenosis is around 10% in simple lesions and is expected to be higher in diabetic patients, long lesions and multi-vessel diseases; a restudy at 9 months actually confers better protection to the patients with advanced disease and any restenosis can be treated timely. All data on clinical events and progress will be monitored and regular follow-ups will be carried out.

Conditions

  • Coronary Restenosis
  • Coronary Thrombosis

Interventions

DEVICE

COMBO Stent (OrbusNeich Medical, Fort Lauderdale, Florida)

The COMBO Stent is a hybrid version of the GENOUS Stent. Upon implantation to the coronary artery, the stent will deliver a drug (sirolimus) to the wall of the treated segment to suppress neointimal growth, in addition to the anti-CD34 antibody coating which will in theory attract circulatory endothelial progenitor cells to hasten endothelialization and promote healing of the stented segment, and thereby may reduce late stent thrombosis.

Sponsors & Collaborators

  • Prof. Stephen Lee

    lead OTHER

Principal Investigators

  • Stephen Lee, MD FRCP FACC · Queen Mary Hospital, The Unversity of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Hong Kong

Study Locations

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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 NCT01274234 on ClinicalTrials.gov