Coronary Artery DiseasePhase 4CRONUSNCT01090609
Study to Evaluate the Safety of Cronus® - Cobalt Chromium Coronary Stent
A Phase 4 study testing Stent implantation in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 13 sites in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 13 sitesBrazil
- Study dates
- May 2010to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤75 years;
- Symptomatic cardiac ischemic disease and/or documented evidence of myocardial ischemia;
- Types B1 and B2 coronary lesions (according to the ACC/AHA classification modified by Ellis);
- Target lesion located in a native coronary artery;
- 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;
- Target lesion with >50% diameter stenosis (by visual estimate);
- Acceptable candidate to myocardial revascularization surgery (coronary artery bypass graft surgery);
- 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.
Who cannot join
- Female patients of childbearing potential;
- 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;
- Documented left ventricular ejection fraction <30%;
- Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);
- Platelet count <100,000 cells/mm³ or >700,000 cells/mm³.;
- White blood cell count <3,000 cells/mm3;
Show all 27Show fewer
- Suspected or documented hepatic disease (including laboratorial evidence of hepatitis);
- Heart transplant receptor;
- Known hypersensitivity to cobalt-chromium or to medications such as aspirin, clopidogrel bisulfate (Plavix or ISCOVER), ticlopidine (Ticlid) or heparin.
- Concurrent medical condition with a life expectancy of less than 12 months;
- Any major medical condition that, in the Investigator's opinion, may interfere with the optimal participation of the patient in this study;
- 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;
- Coronary angioplasty (with or without stenting) less than 9 months before the index procedure at any site of the target vessel;
- 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.
- 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:
- Restenotic target lesion;
- More than one lesion requiring treatment in the same vessel;
- Target vessel diameter <2.5 mm or >3.5 mm (by visual estimation);
- Long target lesion not amenable to treatment (coverage) with a 19-mm-long stent;
- Unprotected coronary artery branch lesion (≥50% diameter stenosis)
- Target lesion is located in a surgical bypass graft;
- Total vessel occlusion (TIMI flow grade 0-1);
- Target lesion with ostial location;
- Target lesion located in a lateral branch bifurcation >2.5mm or requiring lateral branch stenting;
- Calcified target lesion that anticipates unsuccessful/impracticable predilation;
- Target vessel with excessive tortuosity
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Brazil13 sites
Irmandade Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais
Hospital Santa Isabel
Blumenau, Santa Catarina, 89010-906
São Bernardo Apart Hospital
Colatina - ES, 29700-790
Santa Casa de Franca
Franca - SP, 14400-730
Hospital São Salvador Goiânia
Goiânia, Goiás, 74110-020
Hospital Santa Genoveva
Goiânia, Goiás, 74670-430
Hospital Vera Cruz
Patos de Minas - MG, 38700-160
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recife - PE, 50070-050
Santa Casa de Misericórdia de São José do Rio Preto
São José Do Rio Preto - SP
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909
Instituto de Assistência Médica ao Servidor Público Estadual - Iamspe
São Paulo, São Paulo, 04029-000
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-000
Hospital São Paulo - UNIFESP
São Paulo, São Paulo
About this study
Official title: Multicenter, Prospective, Non-randomized Study to Evaluate the Safety of Cronus® Cobalt Chromium Coronary Stent - Study After 9 Months
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:
- reduced acute complications, such as acute and subacute occlusion, as well as the need of urgent myocardial revascularization;
- 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Stent implantation
- Keywords
- Coronary Stent, Cobalt-Chromium coronary stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent implantationDevice
Also called Angioplasty
Stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Stent implantation | Experimental | Cronus Stent implantation Receives: Device: Stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2012
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fausto Feres, Medicine, Principal investigator, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090609
- Sponsor's protocol ID
- Scitech 002
- Acronym
- CRONUS
- Status last verified
- Nov 2014
- First submitted
- 18 Mar 2010
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Non-randomized Study to Evaluate the Safety of Cronus® Cobalt Chromium Coronary Stent - Study After 9 Months
- ClinicalTrials.gov ID
- NCT01090609
- Acronym / sponsor ID
- CRONUS / Scitech 002
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Stent, Cobalt-Chromium coronary stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The use of coronary stents has optimized the results of coronary balloon angioplasty for two reasons:
- reduced acute complications, such as acute and subacute occlusion, as well as the need of urgent myocardial revascularization;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent implantation | Experimental | Device: Stent implantationCronus Stent implantation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years and ≤75 years;
- Symptomatic cardiac ischemic disease and/or documented evidence of myocardial ischemia;
- Types B1 and B2 coronary lesions (according to the ACC/AHA classification modified by Ellis);
- Target lesion located in a native coronary artery;
- 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;
Key exclusion criteria (27 listed)
- Female patients of childbearing potential;
- 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;
- Documented left ventricular ejection fraction <30%;
- Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);
- Platelet count <100,000 cells/mm³ or >700,000 cells/mm³.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent implantationAlso: AngioplastyStent implantation | Device | Stent implantation |
Primary outcome
Clinical Follow-up
Time frame: 30 days after the procedure
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
- Sponsor siteLink provided by the sponsor.
- National Information System on Ethics in Research involving HumanLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fausto Feres, Medicine principal investigator
Instituto Dante Pazzanese de Cardiologia
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stent implantation in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 13 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Follow-up (time frame: 30 days after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.