Trial record 11 of 95 for:    CHROMIUM

Study to Evaluate the Safety of Cronus® - Cobalt Chromium Coronary Stent (CRONUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Scitech Produtos Medicos Ltda.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier:
NCT01090609
First received: March 18, 2010
Last updated: July 4, 2012
Last verified: July 2010
  Purpose

The objective this study is evaluate the performance and safety of Chronus® cobalt-chromium coronary stent in patients with "de novo" native coronary artery lesions treated with 19-mm-long stents in long-term 9 months.


Condition Intervention Phase
Coronary Artery Disease
Coronary Angiography
Device: Cronus® - Cobalt Chromium Coronary Stent (Angioplasty)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Prospective, Non-randomized Study to Evaluate the Safety of Cronus® Cobalt Chromium Coronary Stent - Study After 9 Months

Resource links provided by NLM:


Further study details as provided by Scitech Produtos Medicos Ltda:

Primary Outcome Measures:
  • Clinical Follow-up [ Time Frame: 30 days after the procedure ] [ Designated as safety issue: Yes ]
    All patients are invited to return for a clinical visit at 30 days post-procedure to evaluate possible adverse events and on the continuity of cardiac medication.


Estimated Enrollment: 300
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cronus Stent
Cronus® stent is fabricated in cobalt-chromium. This alloy is currently used cardiovascular stents and permanent implants in orthopedic (hips, knees), dental and maxillofacial surgeries.
Device: Cronus® - Cobalt Chromium Coronary Stent (Angioplasty)
Site preparation and percutaneous access should be performed as per standard hospital procedures. It is recommended to cross the target lesion with 0,014-inches exchange guidewire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care. A stent consists of an endovascular prothesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.
Other Name: Angiography, Stenting

Detailed Description:

The use of coronary stents has optimized the results of coronary balloon angioplasty for two reasons:

  1. reduced acute complications, such as acute and subacute occlusion, as well as the need of urgent myocardial revascularization;
  2. reduced coronary restenosis. STRESS and BENESTENT 1 pivotal clinical trials7,9 laid the foundations for approval and confirmation of the efficacy of coronary stents. These studies showed a reduction in the binary angiographic restenosis rates from 42.1% to 31.6% (p<0.05) and from 32% to 22% (p=0.02), respectively. The efficacy of coronary stents is due to the fact that these devices reduce the acute elastic recoil and late negative remodeling of coronary arteries because of their capacity to maintain the vessel adequately open without reducing vessel diameter.

Cronus® stent is fabricated in cobalt-chromium. This alloy is currently used cardiovascular stents and permanent implants in orthopedic (hips, knees), dental and maxillofacial surgeries. Guidant and Medtronic have conducted clinical evaluations of stents fabricated with a similar cobalt-chromium alloy and demonstrated safety and efficacy of the investigational devices. Both stents are currently available in the European market.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years and ≤75 years;
  2. Symptomatic cardiac ischemic disease and/or documented evidence of myocardial ischemia;
  3. Types B1 and B2 coronary lesions (according to the ACC/AHA classification modified by Ellis);
  4. Target lesion located in a native coronary artery;
  5. Target lesion in vessel with diameter ranging from 2.5 to 3.5 mm (by visual estimate) amenable to treatment (coverage) with a 19-mm-long stent;
  6. Target lesion with >50% diameter stenosis (by visual estimate);
  7. Acceptable candidate to myocardial revascularization surgery (coronary artery bypass graft surgery);
  8. The subject has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.

Exclusion Criteria:

  1. Female patients of childbearing potential;
  2. Recent Q-wave myocardial infarction occurred within 48 hours prior to the index procedure. Recent Q-wave or non-Q-wave myocardial infarction with still elevated levels of cardiac markers;
  3. Documented left ventricular ejection fraction <30%;
  4. Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);
  5. Platelet count <100,000 cells/mm³ or >700,000 cells/mm³.;
  6. White blood cell count <3,000 cells/mm3;
  7. Suspected or documented hepatic disease (including laboratorial evidence of hepatitis);
  8. Heart transplant receptor;
  9. Known hypersensitivity to cobalt-chromium or to medications such as aspirin, clopidogrel bisulfate (Plavix or ISCOVER), ticlopidine (Ticlid) or heparin.
  10. Concurrent medical condition with a life expectancy of less than 12 months;
  11. Any major medical condition that, in the Investigator's opinion, may interfere with the optimal participation of the patient in this study;
  12. Subject is currently participating in an investigational drug or another device study, including planned participation in an investigational drug or another device study during the course of the present investigation;
  13. Coronary angioplasty (with or without stenting) less than 9 months before the index procedure at any site of the target vessel;
  14. Previous coronary angioplasty (with or without stenting) at any time (>9 months) in a vessel segment less than 5 mm proximal or distal to the target lesion.
  15. Planned coronary angioplasty (with or without stenting) in the first 12 months after the index procedure in any segment of the target vessel;

Angiography Exclusion Criteria:

  1. Restenotic target lesion;
  2. More than one lesion requiring treatment in the same vessel;
  3. Target vessel diameter <2.5 mm or >3.5 mm (by visual estimation);
  4. Long target lesion not amenable to treatment (coverage) with a 19-mm-long stent;
  5. Unprotected coronary artery branch lesion (≥50% diameter stenosis)
  6. Target lesion is located in a surgical bypass graft;
  7. Total vessel occlusion (TIMI flow grade 0-1);
  8. Target lesion with ostial location;
  9. Target lesion located in a lateral branch bifurcation >2.5mm or requiring lateral branch stenting;
  10. Calcified target lesion that anticipates unsuccessful/impracticable predilation;
  11. Target vessel with excessive tortuosity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090609

Contacts
Contact: Renata M. Viana, Medicine 55 11 5085-6325 rviana@dantepazzanese.org.br
Contact: Juliana P. Costa, Biology 55 11 5085-6325 jpcosta@dantepazzanese.org.br

Locations
Brazil
Hospital São Salvador Goiânia Recruiting
Goiânia, GO, Brazil, 74110-020
Contact: Hernando Nazzetta, Medicine    55 62 3223-2004    hernando@brturbo.com.br   
Principal Investigator: Hernando Nazzetta, Medicine         
Hospital Santa Genoveva Recruiting
Goiânia, GO, Brazil, 74670-430
Contact: Hernando Nazzetta, Medicine    55 62 3264-9000    hernando@brturbo.com.br   
Principal Investigator: Hernando Nazzetta, Medicine         
Irmandade Santa Casa de Misericórdia de Belo Horizonte Recruiting
Belo Horizonte, MG, Brazil
Contact: Augusto L. Filho, Medicine    55 31 3238-8100    saulolima@terra.com.br   
Principal Investigator: Augusto L. Filho, Medicine         
Hospital Santa Isabel Recruiting
Blumenau, SC, Brazil, 89010-906
Contact: Adrian Kormann, Medicine    55 47 3321-1000    adrianmk@terra.com.br   
Principal Investigator: Adrian Kormann, Medicine         
Instituto de Assistência Médica ao Servidor Público Estadual - Iamspe Recruiting
São Paulo, SP, Brazil, 04029-000
Contact: George Cesar X. Meireles, Medicine    55 11 5088-8452    cepiamspe@ig.com.br   
Principal Investigator: George Cesar X. Meireles, Medicine         
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP Recruiting
São Paulo, SP, Brazil, 05403-000
Contact: Patrícia Pereira, Biomedicine    55 11 3069-5571    patricia.pereira@incor.usp.br   
Principal Investigator: Expedito E. Ribeiro da Silva, Medicine         
Sub-Investigator: Augusto Celso, Medicine         
Sub-Investigator: Henrique Ribeiro, Medicine         
Sub-Investigator: Rodrigo Esper, Medicine         
Hospital São Paulo - UNIFESP Recruiting
São Paulo, SP, Brazil
Contact: Karina Hoshino, Biomedicine    55 11 5572-1134    hoshinoky@yahoo.com.br   
Principal Investigator: Valter Lima, Medicine         
Instituto Dante Pazzanese de Cardiologia Recruiting
São Paulo, SP, Brazil, 04012-909
Contact: Renata M. Viana, Medicine    55 11 5085-6325    rviana@dantepazzanese.org.br   
Contact: Juliana P. Costa, Biology    55 11 5085-6325    jpcosta@dantepazzanese.org.br   
Principal Investigator: Fausto Feres, Medicine         
São Bernardo Apart Hospital Recruiting
Colatina - ES, Brazil, 29700-790
Contact: Monick Ribeiro, Nurse    (27) 2102-2255    mribeiro@saobernardoaparthospital.com.br   
Principal Investigator: João Miguel Dantas, Medice         
Santa Casa de Franca Recruiting
Franca - SP, Brazil, 14400-730
Contact: Breno Siqueira, Medice       brenosiqueira@gmail.com   
Principal Investigator: Ricardo Barbosa, Medice         
Sub-Investigator: Breno Siqueira, Medice         
Hospital Vera Cruz Recruiting
Patos de Minas - MG, Brazil, 38700-160
Contact: Alaor Mendes da Cunha Junior, Medice    (34) 3818-1170    alaormendes@yahoo.com.br   
Principal Investigator: Alaor Mendes da Cunha Junior, Medice         
Instituto de Medicina Integral Professor Fernando Figueira - IMIP Recruiting
Recife - PE, Brazil, 50070-050
Contact: Renata Marcolino, Nurse       rlaureane@hotmail.com   
Principal Investigator: Flavio Roberto Azevedo de Oliveira, Medice         
Santa Casa de Misericórdia de São José do Rio Preto Recruiting
São José do Rio Preto - SP, Brazil
Contact: Mari Buchalla, Nurse    (17) 2139.9264    maribuchalla@yahoo.com.br   
Principal Investigator: Mônica Buchalla, Medice         
Sponsors and Collaborators
Scitech Produtos Medicos Ltda
Investigators
Principal Investigator: Fausto Feres, Medicine Instituto Dante Pazzanese de Cardiologia
  More Information

Additional Information:
No publications provided

Responsible Party: Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier: NCT01090609     History of Changes
Other Study ID Numbers: Scitech 002
Study First Received: March 18, 2010
Last Updated: July 4, 2012
Health Authority: United States: Institutional Review Board
Brazil: Ministry of Health

Keywords provided by Scitech Produtos Medicos Ltda:
Coronary Stent
Cobalt-Chromium coronary stent

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

ClinicalTrials.gov processed this record on April 21, 2014