Symptomatic Ischemic Heart DiseasePhase 3CONCISENCT00993785
CoStar Catheter System Evaluation
A Phase 3 study testing Costar Coronary Stent Delivery System in people with Symptomatic Ischemic Heart Disease, run by Conor Medsystems at 1 site in Germany.
Trial summary
To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Ischemic Heart Disease
- What is being tested?
- Costar Coronary Stent Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to Apr 2008
- Phase
- Phase 3
- 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
- Adult, Older adult
Who may be able to join
- Patient is ≥18 years of age.
- Eligible for percutaneous coronary intervention (PCI).
- Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification [CCS] 1, 2, 3, or 4), documented ischemia, or documented silent ischemia.
- Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks.
- Acceptable candidate for coronary artery bypass graft surgery (CABG).
- Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
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- Willing to comply with all specified follow-up evaluations.
- A single de novo lesion per study subject may be treated with the study device.
- Each target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent.
- Cumulative target lesion length per vessel is ≤24 mm based on a visual estimate.
- RVD of ≥2.5 mm to ≤3.0 mm based on a visual estimate.
- Target lesion diameter stenosis ≥50% and <100% based on a visual estimate.
- Target vessel has not undergone prior revascularization within the preceding 6 months.
- Target lesion must be a minimum of 10 mm distance from any previously treated segment of the target vessel
Who cannot join
- Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: PLGA.
- Planned treatment with any other PCI device in the target vessel(s).
- Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q wave, or creatinine kinase (CK) >2 times the laboratory upper limits of normal and elevated MB.
- The patient is in cardiogenic shock.
- Cerebrovascular Accident (CVA) within the past 6 months.
- Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/L).
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- Contraindication to ASA or to clopidogrel.
- Thrombocytopenia (platelet count <100, 000/mm3).
- Active gastrointestinal (GI) bleeding within the past three months.
- Any prior true anaphylactic reaction to contrast agents.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz-Kreislauf-Zentrum
Am Kurpark 1, Segeberger Kliniken GmbH, 23795
About this study
To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion.
- Conditions
- Symptomatic Ischemic Heart Disease
- Being tested
- Costar Coronary Stent Delivery System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Costar Coronary Stent Delivery SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| OTW Catheter System | Experimental | Not described Receives: Device: Costar Coronary Stent Delivery System |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startFeb 2007
- Study completionApr 2008
Why it stopped: CoStar Stent IDE failed to meet primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Ischemic Heart 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 3
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conor Medsystems
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993785
- Sponsor's protocol ID
- CP-04
- Acronym
- CONCISE
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoStar Catheter System Evaluation
- ClinicalTrials.gov ID
- NCT00993785
- Acronym / sponsor ID
- CONCISE / CP-04
- Conditions
- Symptomatic Ischemic Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: CoStar Stent IDE failed to meet primary endpoint
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Conor MedsystemsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Oct 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.
To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTW Catheter System | Experimental | Device: Costar Coronary Stent Delivery System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient is ≥18 years of age.
- Eligible for percutaneous coronary intervention (PCI).
- Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification [CCS] 1, 2, 3, or 4), documented ischemia, or documented silent ischemia.
- Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks.
- Acceptable candidate for coronary artery bypass graft surgery (CABG).
Key exclusion criteria (10 listed)
- Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: PLGA.
- Planned treatment with any other PCI device in the target vessel(s).
- Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q wave, or creatinine kinase (CK) >2 times the laboratory upper limits of normal and elevated MB.
- The patient is in cardiogenic shock.
- Cerebrovascular Accident (CVA) within the past 6 months.
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 Coronary Stent Delivery System | Device | OTW Catheter System |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: CoStar Stent IDE failed to meet primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Costar Coronary Stent Delivery System in people with Symptomatic Ischemic Heart Disease, run by Conor Medsystems at 1 site in Germany.
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 14 inclusion and 10 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 29 Oct 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: CoStar Stent IDE failed to meet primary endpoint). 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.
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 29 Oct 2009.