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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier:
NCT01090609
First received: March 18, 2010
Last updated: November 13, 2014
Last verified: November 2014
  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
Device: Stent implantation
Phase 4

Study Type: Interventional
Study Design: 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

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.


Enrollment: 263
Study Start Date: May 2010
Study Completion Date: November 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stent implantation
Cronus Stent implantation
Device: Stent implantation
Stent implantation
Other Name: Angioplasty

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
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 ClinicalTrials.gov identifier: NCT01090609

Locations
Brazil
Hospital Santa Genoveva
Goiânia, GO, Brazil, 74670-430
Hospital São Salvador Goiânia
Goiânia, GO, Brazil, 74110-020
Irmandade Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, MG, Brazil
Hospital Santa Isabel
Blumenau, SC, Brazil, 89010-906
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, SP, Brazil, 05403-000
Instituto Dante Pazzanese de Cardiologia
São Paulo, SP, Brazil, 04012-909
Instituto de Assistência Médica ao Servidor Público Estadual - Iamspe
São Paulo, SP, Brazil, 04029-000
Hospital São Paulo - UNIFESP
São Paulo, SP, Brazil
São Bernardo Apart Hospital
Colatina - ES, Brazil, 29700-790
Santa Casa de Franca
Franca - SP, Brazil, 14400-730
Hospital Vera Cruz
Patos de Minas - MG, Brazil, 38700-160
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recife - PE, Brazil, 50070-050
Santa Casa de Misericórdia de São José do Rio Preto
São José do Rio Preto - SP, Brazil
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: November 13, 2014
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:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Chromium
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 24, 2014