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

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ClinicalTrials.gov Identifier: NCT00920283
Recruitment Status : Unknown
Verified February 2012 by CID - Carbostent & Implantable Devices.
Recruitment status was:  Recruiting
First Posted : June 15, 2009
Last Update Posted : February 22, 2012
Information provided by:
CID - Carbostent & Implantable Devices

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.

Condition or disease Intervention/treatment Phase
Coronary Atherosclerotic Disease Coronary Occlusive Diseases Coronary Artery Diseases Myocardial Ischemia Coronary Stenosis Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent Device: Driver Cobalt Alloy Coronary Stent Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions
Study Start Date : July 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : April 2013

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

Primary Outcome Measures :
  1. in-stent late lumen loss (LLL) [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Angiographic binary restenosis (diameter stenosis ≥50%) [ Time Frame: 180 days ]
  2. 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 ]
  3. Stent Thrombosis [ Time Frame: acute, 30 days, 180 days, 1 year ]
  4. Acute success (Device and Procedural success) [ Time Frame: acute ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920283

Contact: Flavio Airoldi, Dr +39 02 24209335 flavio.airoldi@yahoo.it

Maria Cecilia Hospital Recruiting
Cotignola, Ravenna, Italy, 48010
Principal Investigator: Alberto Cremonesi, Doctor         
Cardinal Massaia Hospital Recruiting
Asti, Italy, 14100
Principal Investigator: Antonio Montefusco, Doctor         
Azienda Ospedaliera Policlinico di Modena Active, not recruiting
Modena, Italy
Ospedale Civile S.Agostino-Estense-Baggiovara Active, not recruiting
Modena, Italy
Azienda Ospedaliera Universitaria Active, not recruiting
Roma, Italy
Ospedale Civile Maggiore- Borgo Trento Active, not recruiting
Verona, Italy
Sponsors and Collaborators
CID - Carbostent & Implantable Devices
Principal Investigator: Flavio Airoldi, Dr Multimedica IRCCS, Sesto SG (MI) Italy

Responsible Party: Carbostent & Implantable Devices
ClinicalTrials.gov Identifier: NCT00920283     History of Changes
Other Study ID Numbers: C10901
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by CID - Carbostent & Implantable Devices:
Bare Metal Stents
Coronary Artery Disease
Coronary Artery Stenosis
Stent Thrombosis
Vascular Disease
Myocardial Ischemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Trace Elements
Growth Substances
Physiological Effects of Drugs