Coronary DiseaseNCT00415961
Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety
A study testing CoStar Paclitaxel Drug-Eluting Coronary Stent System in people with Coronary Disease, run by Conor Medsystems at 1 site in Japan.
Trial summary
This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- CoStar Paclitaxel Drug-Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2006to May 2012
- 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 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria
- Eligible for percutaneous coronary intervention (PCI)
- Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
- Documented LVEF ≥25% within the last 6 weeks.
- Eligible for coronary artery bypass graft surgery (CABG)
Who cannot join
- General Exclusion Criteria: -
- Known sensitivity to paclitaxel or polymeric matrices.
- Planned treatment with any other PCI device in the target vessel(s).
- MI within 72 hours prior to the index procedure
- Patient is in cardiogenic shock
- Cerebrovascular Accident (CVA) within the past 6 months
Show all 12Show fewer
- Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/L)
- Contraindication to ASA or to ticlopidine
- Thrombocytopenia
- Active GI bleeding within past three months
- Known allergy to cobalt chromium
- Any prior true anaphylactic reaction to contrast agents
Trial locations and contacts
1 site in 1 country.
About this study
This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.
Read the detailed description
This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be used for comparison.
- Conditions
- Coronary Disease
- Being tested
- CoStar Paclitaxel Drug-Eluting Coronary Stent System
- Keywords
- Percutaneous Coronary Intervention (PCI), Drug-eluting stent (DES)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoStar Paclitaxel Drug-Eluting Coronary Stent SystemDevice
CoStar Paclitaxel Drug-Eluting Coronary Stent System
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CoStar Paclitaxel drug eluting stent Receives: Device: CoStar Paclitaxel Drug-Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late lumen loss at 9 months, as measured by QCA.
Measured: 9 months
Secondary outcomes (1)
Device, lesion and procedure success; MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months
Measured: MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startNov 2006
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Conor Medsystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Getz Pharma
- Investigators
- Shigeru Saito, MD, Principal investigator, ShonanKamakura General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415961
- Sponsor's protocol ID
- CI-CMS-005
- Status last verified
- Jan 2009
- First submitted
- 22 Dec 2006
- Last updated
- 9 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety
- ClinicalTrials.gov ID
- NCT00415961
- Acronym / sponsor ID
- CI-CMS-005
- Conditions
- Coronary Disease
- Keywords
- Percutaneous Coronary Intervention (PCI), Drug-eluting stent (DES)
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Conor MedsystemsIndustry (pharma, biotech, devices)
- Collaborators
- Getz Pharma
- Study start
- Nov 2006
- Study completion
- May 2012 (estimated)
- First posted
- 27 Dec 2006 (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.
This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.
Detailed description
This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be used for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CoStar Paclitaxel Drug-Eluting Coronary Stent SystemCoStar Paclitaxel drug eluting stent |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- General Inclusion Criteria
- Eligible for percutaneous coronary intervention (PCI)
- Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
- Documented LVEF ≥25% within the last 6 weeks.
- Eligible for coronary artery bypass graft surgery (CABG)
Key exclusion criteria (12 listed)
- General Exclusion Criteria: -
- Known sensitivity to paclitaxel or polymeric matrices.
- Planned treatment with any other PCI device in the target vessel(s).
- MI within 72 hours prior to the index procedure
- Patient is in cardiogenic shock
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 |
|---|---|---|
| CoStar Paclitaxel Drug-Eluting Coronary Stent SystemCoStar Paclitaxel Drug-Eluting Coronary Stent System | Device | 1 |
Primary outcome
In-segment late lumen loss at 9 months, as measured by QCA.
Time frame: 9 months
1 secondary outcome
Device, lesion and procedure success; MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months
Time frame: MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2009.
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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.
Shigeru Saito, MD principal investigator
ShonanKamakura General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoStar Paclitaxel Drug-Eluting Coronary Stent System in people with Coronary Disease, run by Conor Medsystems at 1 site in Japan.
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 12 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: stopped early, as of the sponsor's last update on 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 was stopped early. Results are not available in the source record.
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-segment late lumen loss at 9 months, as measured by QCA. (time frame: 9 months). 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 9 Jan 2009.