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

Primary Purpose

Coronary Atherosclerotic Disease, Coronary Occlusive Diseases, Coronary Artery Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Chrono Carbostent Carbofilm™ Coated Coronary Stent
Driver Cobalt Alloy Coronary Stent
Sponsored by
CID - Carbostent & Implantable Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Atherosclerotic Disease focused on measuring Stents, Bare Metal Stents, PCI, Coronary Artery Disease, Coronary Artery Stenosis, Stent Thrombosis, Vascular Disease, Myocardial Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maria Cecilia Hospital
  • Cardinal Massaia Hospital
  • Azienda Ospedaliera Policlinico di Modena
  • Ospedale Civile S.Agostino-Estense-Baggiovara
  • Azienda Ospedaliera Universitaria
  • Ospedale Civile Maggiore- Borgo Trento

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chrono Carbostent Carbofilm™ Coated Coronary Stent

Driver, Cobalt Alloy Coronary Stent

Arm Description

Outcomes

Primary Outcome Measures

in-stent late lumen loss (LLL)

Secondary Outcome Measures

Angiographic binary restenosis (diameter stenosis ≥50%)
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
Stent Thrombosis
Acute success (Device and Procedural success)

Full Information

First Posted
June 12, 2009
Last Updated
May 2, 2018
Sponsor
CID - Carbostent & Implantable Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00920283
Brief Title
COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent
Acronym
COMPETE
Official Title
Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (Actual)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CID - Carbostent & Implantable Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerotic Disease, Coronary Occlusive Diseases, Coronary Artery Diseases, Myocardial Ischemia, Coronary Stenosis
Keywords
Stents, Bare Metal Stents, PCI, Coronary Artery Disease, Coronary Artery Stenosis, Stent Thrombosis, Vascular Disease, Myocardial Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chrono Carbostent Carbofilm™ Coated Coronary Stent
Arm Type
Experimental
Arm Title
Driver, Cobalt Alloy Coronary Stent
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Chrono Carbostent Carbofilm™ Coated Coronary Stent
Intervention Type
Device
Intervention Name(s)
Driver Cobalt Alloy Coronary Stent
Primary Outcome Measure Information:
Title
in-stent late lumen loss (LLL)
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Angiographic binary restenosis (diameter stenosis ≥50%)
Time Frame
180 days
Title
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
Title
Stent Thrombosis
Time Frame
acute, 30 days, 180 days, 1 year
Title
Acute success (Device and Procedural success)
Time Frame
acute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio Airoldi, Dr
Organizational Affiliation
Multimedica IRCCS, Sesto SG (MI) Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Cecilia Hospital
City
Cotignola
State/Province
Ravenna
ZIP/Postal Code
48010
Country
Italy
Facility Name
Cardinal Massaia Hospital
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico di Modena
City
Modena
Country
Italy
Facility Name
Ospedale Civile S.Agostino-Estense-Baggiovara
City
Modena
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria
City
Roma
Country
Italy
Facility Name
Ospedale Civile Maggiore- Borgo Trento
City
Verona
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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