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Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS

NCT01543373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-04-30

No results posted yet for this study

Summary

The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.

Conditions

  • Stable Angina
  • Unstable Angina
  • NSTEMI

Interventions

DEVICE

Amphilimus Eluting Stent

Sirolimus formulated coronary eluting stent

DEVICE

Bare Metal Stent

Bare metal coronary stent

Sponsors & Collaborators

  • CID - Carbostent & Implantable Devices

    lead INDUSTRY

Principal Investigators

  • Francesco Prati, MD · Ospedale S. Giovanni - Addolorata

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-08-31
Completion
2014-04-30

Countries

  • Italy
  • Netherlands

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 NCT01543373 on ClinicalTrials.gov