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COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms (CONFIRM 1)

NCT00689767 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2013-04-17

No results posted yet for this study

Summary

This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7 sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point for all subjects.

Conditions

Interventions

DEVICE

CINATRA™ Coronary Stent System

Bare metal cobalt chromium stent implantation

DEVICE

CINATRA™ ISA 247 Coated Coronary Stent System

Drug coated cobalt chromium stent implantation

Sponsors & Collaborators

  • Atrium Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Glenn Van Langenhove, MD · Middelheim Hospital, Antwerp, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-06-30
Completion
2012-07-31

Countries

  • Belgium

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 NCT00689767 on ClinicalTrials.gov