COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent (COMPETE)

May 2, 2018 updated by: CID - Carbostent & Implantable Devices

Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions

The COMPETE study is a prospective,randomized,two-arm multi-center clinical trial comparing two commercially available coronary stents: Chrono Carbostent Carbofilm™ Coated vs Driver/Micro-Driver Coronary Stent System. In this study, 204 subjects will be included (2:1 randomization Chrono:Driver/Micro Driver) in 6 Italian sites.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Asti, Italy, 14100
        • Cardinal Massaia Hospital
      • Modena, Italy
        • Azienda Ospedaliera Policlinico di Modena
      • Modena, Italy
        • Ospedale Civile S.Agostino-Estense-Baggiovara
      • Roma, Italy
        • Azienda Ospedaliera Universitaria
      • Verona, Italy
        • Ospedale Civile Maggiore- Borgo Trento
    • Ravenna
      • Cotignola, Ravenna, Italy, 48010
        • Maria Cecilia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with clinical evidence of ischemic heart disease;
  • No clinical and ECG changes suggestive of ongoing acute infarction;
  • De novo lesion > 50% and <100% diameter stenosis (DS) in native coronary vessels TIMI flow of >= 1.
  • Reference diameter > 2.5 mm or < 4.0 mm;
  • Patients with a maximum of two coronary lesions to be treated with a maximum of 2 study stents;

Exclusion Criteria:

  • Lesion length > 30 mm;
  • Significant (>50%) stenosis proximal or distal to the target lesions that might impede run off;
  • Lesions located in saphenous vein graft;
  • Lesions located in unprotected left main;
  • Presence of > 40% stenosis in the left main;
  • Ostial lesion;
  • Lesion located in a bifurcation;
  • Target lesion with visible thrombus;
  • Chronic total occlusion;
  • Treatment of restenotic lesions;
  • Previous implantation of a stent (BMS/DES) in the target vessel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chrono Carbostent Carbofilm™ Coated Coronary Stent
Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent
Active Comparator: Driver, Cobalt Alloy Coronary Stent
Device: Driver Cobalt Alloy Coronary Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
in-stent late lumen loss (LLL)
Time Frame: 180 days
180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Angiographic binary restenosis (diameter stenosis ≥50%)
Time Frame: 180 days
180 days
Clinical Composite Endpoints: - Cardiac death/ MI - Cardiac death / Target vessel MI / (Clinically indicated) TLR* - All death / MI / all repeat revascularization** *Device oriented composite endpoint **Patient oriented composite endpoint
Time Frame: 30 days, 180 days, 1 year
30 days, 180 days, 1 year
Stent Thrombosis
Time Frame: acute, 30 days, 180 days, 1 year
acute, 30 days, 180 days, 1 year
Acute success (Device and Procedural success)
Time Frame: acute
acute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CID - Carbostent & Implantable Devices

Investigators

  • Principal Investigator: Flavio Airoldi, Dr, Multimedica IRCCS, Sesto SG (MI) Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 12, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C10901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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