MedTrace Logo

CRE8 in All Comers Patients

NCT01687075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2016-06-28

No results posted yet for this study

Summary

The purpose of the study is to evaluate clinical performances of Cre8 in all comer population in Subjects over 18 years old who are undergoing a clinically indicated coronary angiogram and angioplasty on de-novo lesion located in native coronary arteries

Conditions

  • Consecutive Subjects Who Are Suitable for a Coronary
  • Angioplasty of de Novo Lesion(s) in Native Coronary
  • Arteries Should be Screened for Eligibility.
  • A Total Number of 200 Patients Fulfilling the Selection
  • Criteria and Willing to Sign the Informed Consent Should
  • be Enrolled in the Trial.

Interventions

DEVICE

CR8 a drug eluting coronary stent

a drug eluting coronary device, made of Cobalt-Chromium alloy and integrally coated with i-Carbofilm™, loaded with formulated Sirolimus

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Shmuel Banai, Prof · Tel Aviv Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • Israel

Study Locations

More Related Trials

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 NCT01687075 on ClinicalTrials.gov