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

This study is currently recruiting participants.
Verified February 2012 by CID - Carbostent & Implantable Devices
Sponsor:
Information provided by:
CID - Carbostent & Implantable Devices
ClinicalTrials.gov Identifier:
NCT00920283
First received: June 12, 2009
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920283

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

Locations
Italy
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            
Ospedale Civile S.Agostino-Estense-Baggiovara Active, not recruiting
Modena, Italy
Azienda Ospedaliera Policlinico di Modena 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
Investigators
Principal Investigator: Flavio Airoldi, Dr Multimedica IRCCS, Sesto SG (MI) Italy
  More Information

No publications provided

Responsible Party: Carbostent & Implantable Devices
ClinicalTrials.gov 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:
Stents
Bare Metal Stents
PCI
Coronary Artery Disease
 Coronary Artery Stenosis
Stent Thrombosis
Vascular Disease
Myocardial Ischemia

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

ClinicalTrials.gov processed this record on May 16, 2013