Coronary Atherosclerotic DiseaseCOMPETENCT00920283
COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent
A study testing Chrono Carbostent Carbofilm™ Coated Coronary Stent and Driver Cobalt Alloy Coronary Stent in people with Coronary Atherosclerotic Disease and Coronary Occlusive Diseases, run by CID - Carbostent & Implantable Devices at 6 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Atherosclerotic Disease, Coronary Occlusive Diseases, Coronary Artery Diseases
- What is being tested?
- Chrono Carbostent Carbofilm™ Coated Coronary Stent and Driver Cobalt Alloy Coronary Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 6 sitesItaly
- Study dates
- Jul 2009to Jun 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Cardinal Massaia Hospital
Asti, 14100
Maria Cecilia Hospital
Cotignola, Ravenna, 48010
Azienda Ospedaliera Policlinico di Modena
Modena
Ospedale Civile S.Agostino-Estense-Baggiovara
Modena
Azienda Ospedaliera Universitaria
Roma
Ospedale Civile Maggiore- Borgo Trento
Verona
About this study
Official title: Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions
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.
- Conditions
- Coronary Atherosclerotic Disease, Coronary Occlusive Diseases, Coronary Artery Diseases, Myocardial Ischemia, Coronary Stenosis
- Being tested
- Chrono Carbostent Carbofilm™ Coated Coronary Stent, Driver Cobalt Alloy Coronary Stent
- Keywords
- Stents, Bare Metal Stents, PCI, Coronary Artery Disease, Coronary Artery Stenosis, Stent Thrombosis, Vascular Disease, Myocardial Ischemia
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Stenosis, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chrono Carbostent Carbofilm™ Coated Coronary StentDevice
Driver Cobalt Alloy Coronary StentDevice
| Study group | Role | What they receive |
|---|---|---|
| Chrono Carbostent Carbofilm™ Coated Coronary Stent | Experimental | Not described Receives: Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent |
| Driver, Cobalt Alloy Coronary Stent | Active comparator | Not described Receives: Device: Driver Cobalt Alloy Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-stent late lumen loss (LLL)
Measured: 180 days
Secondary outcomes (4)
Angiographic binary restenosis (diameter stenosis ≥50%)
Measured: 180 days
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
Measured: 30 days, 180 days, 1 year
Stent Thrombosis
Measured: acute, 30 days, 180 days, 1 year
Acute success (Device and Procedural success)
Measured: acute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Atherosclerotic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- CID - Carbostent & Implantable Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Flavio Airoldi, Dr, Principal investigator, Multimedica IRCCS, Sesto SG (MI) Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920283
- Sponsor's protocol ID
- C10901
- Acronym
- COMPETE
- Status last verified
- May 2018
- First submitted
- 12 Jun 2009
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00920283
- Acronym / sponsor ID
- COMPETE / C10901
- Conditions
- Coronary Atherosclerotic Disease, Coronary Occlusive Diseases, Coronary Artery Diseases, Myocardial Ischemia, Coronary Stenosis
- Keywords
- Stents, Bare Metal Stents, PCI, Coronary Artery Disease, Coronary Artery Stenosis, Stent Thrombosis, Vascular Disease, Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- CID - Carbostent & Implantable DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2009 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Jun 2009 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chrono Carbostent Carbofilm™ Coated Coronary Stent | Experimental | Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent |
| Driver, Cobalt Alloy Coronary Stent | Active comparator | Device: Driver Cobalt Alloy Coronary Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
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 |
|---|---|---|
| Chrono Carbostent Carbofilm™ Coated Coronary Stent | Device | Chrono Carbostent Carbofilm™ Coated Coronary Stent |
| Driver Cobalt Alloy Coronary Stent | Device | Driver, Cobalt Alloy Coronary Stent |
Primary outcome
in-stent late lumen loss (LLL)
Time frame: 180 days
4 secondary outcomes
Angiographic binary restenosis (diameter stenosis ≥50%)
Time frame: 180 days
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
Stent Thrombosis
Time frame: acute, 30 days, 180 days, 1 year
Acute success (Device and Procedural success)
Time frame: acute
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 7 May 2018.
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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.
Flavio Airoldi, Dr principal investigator
Multimedica IRCCS, Sesto SG (MI) Italy
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chrono Carbostent Carbofilm™ Coated Coronary Stent and Driver Cobalt Alloy Coronary Stent in people with Coronary Atherosclerotic Disease and Coronary Occlusive Diseases, run by CID - Carbostent & Implantable Devices at 6 sites in Italy.
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 5 inclusion and 11 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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.
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?
in-stent late lumen loss (LLL) (time frame: 180 days). 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 7 May 2018.