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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 : Completed
First Posted : June 15, 2009
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 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
Actual Study Start Date : July 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cobalt
U.S. FDA Resources

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 ]


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

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


Locations
Italy
Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48010
Cardinal Massaia Hospital
Asti, Italy, 14100
Azienda Ospedaliera Policlinico di Modena
Modena, Italy
Ospedale Civile S.Agostino-Estense-Baggiovara
Modena, Italy
Azienda Ospedaliera Universitaria
Roma, Italy
Ospedale Civile Maggiore- Borgo Trento
Verona, Italy
Sponsors and Collaborators
CID - Carbostent & Implantable Devices
Investigators
Principal Investigator: Flavio Airoldi, Dr Multimedica IRCCS, Sesto SG (MI) Italy

Responsible Party: CID - 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: May 7, 2018
Last Verified: May 2018

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

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