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CompletedNCT01090609CRONUSUpdated Nov 14, 2014

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

A Phase 4 interventional study of Stent implantation in Coronary Artery Disease, sponsored by Scitech Produtos Medicos Ltda. Completed at 13 sites in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-11-14.

Sponsored by Scitech Produtos Medicos Ltda · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
263
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary Stent
  • Cobalt-Chromium coronary stent
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 263 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Scitech Produtos Medicos Ltda is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
263 participants (actual)

Study arms

  • Experimental
    Stent implantation

    Cronus Stent implantation

    Device: Stent implantation

Interventions

  • DeviceStent implantation

    Stent implantation

    Also known as: Angioplasty

06

What researchers measure

Primary outcomes

  1. Clinical Follow-up

    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.

    Time frame: 30 days after the procedure

07

Study locations

13 sites
  • Hospital São Salvador Goiânia
    Goiânia, GO 74110-020, Brazil
  • Hospital Santa Genoveva
    Goiânia, GO 74670-430, Brazil
  • Irmandade Santa Casa de Misericórdia de Belo Horizonte
    Belo Horizonte, MG, Brazil
  • Hospital Santa Isabel
    Blumenau, SC 89010-906, Brazil
  • Instituto Dante Pazzanese de Cardiologia
    São Paulo, SP 04012-909, Brazil
  • Instituto de Assistência Médica ao Servidor Público Estadual - Iamspe
    São Paulo, SP 04029-000, Brazil
  • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
    São Paulo, SP 05403-000, Brazil
  • Hospital São Paulo - UNIFESP
    São Paulo, SP, Brazil
  • São Bernardo Apart Hospital
    Colatina - ES, 29700-790, Brazil
  • Santa Casa de Franca
    Franca - SP, 14400-730, Brazil
  • Hospital Vera Cruz
    Patos de Minas - MG, 38700-160, Brazil
  • Instituto de Medicina Integral Professor Fernando Figueira - IMIP
    Recife - PE, 50070-050, Brazil
  • Santa Casa de Misericórdia de São José do Rio Preto
    São José do Rio Preto - SP, Brazil
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01090609
Lead sponsor
Scitech Produtos Medicos Ltda
Responsible party
Sponsor
First posted
Mar 22, 2010
Start date
May 2010
Primary completion
Sep 2012
Completion
Nov 2014
Last update
Nov 14, 2014

Study contacts

Fausto Feres, Medicine
principal investigator · Instituto Dante Pazzanese de Cardiologia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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