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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by CID - Carbostent & Implantable Devices.
Recruitment status was  Recruiting
Information provided by:
CID - Carbostent & Implantable Devices Identifier:
First received: June 12, 2009
Last updated: February 20, 2012
Last verified: February 2012

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by CID - Carbostent & Implantable Devices:

Primary Outcome Measures:
  • in-stent late lumen loss (LLL) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Angiographic binary restenosis (diameter stenosis ≥50%) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis [ Time Frame: acute, 30 days, 180 days, 1 year ] [ Designated as safety issue: Yes ]
  • Acute success (Device and Procedural success) [ Time Frame: acute ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 204
Study Start Date: July 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00920283

Contact: Flavio Airoldi, Dr +39 02 24209335

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
  More Information

No publications provided

Responsible Party: Carbostent & Implantable Devices Identifier: NCT00920283     History of Changes
Other Study ID Numbers: C10901
Study First Received: June 12, 2009
Last Updated: February 20, 2012
Health Authority: Italy: Ethics Committee

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
Coronary Disease
Coronary Stenosis
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements processed this record on November 25, 2014