Coronary Artery DiseasePhase 4DECIDENCT00440674
Prospective, Multi-Center, Random. Study of CoStar Paclitaxel-Eluting Coronary Stent(Direct Stenting vs. Pre-Dilatation)
A Phase 4 study testing CoStar Paclitaxel-eluting coronary stent system in people with Coronary Artery Disease, run by Conor Medsystems at 1 site in Germany.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of a direct stenting technique compared to conventional stenting with pre-dilatation strategy using the CoStar Paclitaxel-eluting coronary stent system for the treatment of a single de novo lesion in a native coronary artery ≤ 25 mm long… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CoStar Paclitaxel-eluting coronary stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to Jul 2009
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for percutaneous coronary intervention
- Documented stable or unstable angina pectoris or with documented ischemia, or with documented silent ischemia
- Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks
- Acceptable candidate for coronary artery bypass graft surgery
- Single target vessel / single target lesion to be treated
- Target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent
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- Cumulative target lesion length per vessel is ≤ 25 mm
- RVD of 2.5-3.5 mm
- Target lesion diameter stenosis ≥ 50% and < 100%
- Target vessel has not undergone prior revascularization within the preceding 6 months
Who cannot join
- Known sensitivity to cobalt chromium, Paclitaxel or PLGA
- Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q-wave, or a creatine kinase (CK) level of > 2x 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)/
- Contraindication to ASA or to Clopidogrel
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- Thrombocytopenia (platelet count <100,000/mm3)
- Active gastrointestinal (GI) bleeding within the past three months
- Any prior true anaphylactic reaction to contrast agents
- Patient is currently taking Colchicine
- Patient is currently, or has been treated with Paclitaxel (systemic) within12 months of the index procedure
- Comorbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- Left main coronary artery disease (stenosis >50%), whether protected or unprotected.
- Target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter that requires intervention.
- Target lesion is totally occluded Thrombolysis In MI (TIMI flow ≤1).
- The target vessel has had prior drug-eluting stent placement to vessel segment (or branch) proximal to intended target lesion site.
- Angiographic restenosis of any segment of the target vessel that has undergone prior PCI.
- Angiographic evidence of atherosclerotic disease with >50% diameter stenosis (by visual estimate) proximal or distal to the target lesion (applies to the major epicardial portion of the target vessel and contiguous vessel segment if the target lesion is located in a branch vessel)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitäres Herz-und Gefäßzentrum Hamburg
Hamburg, Free and Hanseatic City of Hamburg, D-22527
About this study
Official title: The DECIDE Trial: Prospective, Multi-center, Randomized Study to Evaluate the CoStar Paclitaxel-Eluting Coronary Stent System Using a Direct Stenting Technique Compared to Conventional Stenting With Pre-dilatation Strategy
The primary objective of this study is to evaluate the safety and effectiveness of a direct stenting technique compared to conventional stenting with pre-dilatation strategy using the CoStar Paclitaxel-eluting coronary stent system for the treatment of a single de novo lesion in a native coronary artery ≤ 25 mm long in a native coronary artery 2.5-3.5 mm diameter.
Read the detailed description
Prospective, multi-center, randomized (1:1), open-label study to evaluate direct stenting compared to conventional stenting with pre-dilatation strategy in treatment of a single de novo Lesion of a single native coronary artery in patients undergoing elective percutaneous coronary intervention.
- Conditions
- Coronary Artery Disease
- Being tested
- CoStar Paclitaxel-eluting coronary stent system
- Keywords
- Direct Stenting, Angioplasty, Pre-dilatation, Drug-eluting 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.
CoStar Paclitaxel-eluting coronary stent systemDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Direct stenting technique Receives: Device: CoStar Paclitaxel-eluting coronary stent system |
| 2 | Experimental | Conventional stenting with pre-dilatation strategy Receives: Device: CoStar Paclitaxel-eluting coronary stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjudicated MACE at 30 days
Measured: 30 days
Secondary outcomes (1)
Primary & second. device success, Lesion and Procedure success, Adjudicated MACE 8, 9, 12, 24 mos post-proc; Binary restenosis, MLD, Clin. driven TLR 8 mos post-proc; Clinic. driven TVR 8 mos post-proc; Overall TVR/TLR 8 mos post-proc; Stent thrombosis
Measured: 8, 9, 12, 24 mos post-proc
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2007
- Study completionJul 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conor Medsystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joachim Schofer, Principal investigator, Universitäres Herz-und Gefäßzentrum Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440674
- Sponsor's protocol ID
- The DECIDE Trial: CP-05
- Acronym
- DECIDE
- Status last verified
- Oct 2009
- First submitted
- 23 Feb 2007
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DECIDE Trial: Prospective, Multi-center, Randomized Study to Evaluate the CoStar Paclitaxel-Eluting Coronary Stent System Using a Direct Stenting Technique Compared to Conventional Stenting With Pre-dilatation Strategy
- ClinicalTrials.gov ID
- NCT00440674
- Acronym / sponsor ID
- DECIDE / The DECIDE Trial: CP-05
- Conditions
- Coronary Artery Disease
- Keywords
- Direct Stenting, Angioplasty, Pre-dilatation, Drug-eluting stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Conor MedsystemsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Feb 2007 (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 primary objective of this study is to evaluate the safety and effectiveness of a direct stenting technique compared to conventional stenting with pre-dilatation strategy using the CoStar Paclitaxel-eluting coronary stent system for the treatment of a single de novo lesion in a native coronary artery ≤ 25 mm long in a native coronary artery 2.5-3.5 mm diameter.
Detailed description
Prospective, multi-center, randomized (1:1), open-label study to evaluate direct stenting compared to conventional stenting with pre-dilatation strategy in treatment of a single de novo Lesion of a single native coronary artery in patients undergoing elective percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CoStar Paclitaxel-eluting coronary stent systemDirect stenting technique |
| 2 | Experimental | Device: CoStar Paclitaxel-eluting coronary stent systemConventional stenting with pre-dilatation strategy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eligible for percutaneous coronary intervention
- Documented stable or unstable angina pectoris or with documented ischemia, or with documented silent ischemia
- Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks
- Acceptable candidate for coronary artery bypass graft surgery
- Single target vessel / single target lesion to be treated
Key exclusion criteria (18 listed)
- Known sensitivity to cobalt chromium, Paclitaxel or PLGA
- Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q-wave, or a creatine kinase (CK) level of > 2x 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)/
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-eluting coronary stent system | Device | 1, 2 |
Primary outcome
Adjudicated MACE at 30 days
Time frame: 30 days
1 secondary outcome
Primary & second. device success, Lesion and Procedure success, Adjudicated MACE 8, 9, 12, 24 mos post-proc; Binary restenosis, MLD, Clin. driven TLR 8 mos post-proc; Clinic. driven TVR 8 mos post-proc; Overall TVR/TLR 8 mos post-proc; Stent thrombosis
Time frame: 8, 9, 12, 24 mos post-proc
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 30 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.
Joachim Schofer principal investigator
Universitäres Herz-und Gefäßzentrum Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CoStar Paclitaxel-eluting coronary stent system in people with Coronary Artery 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 10 inclusion and 18 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 30 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 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 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?
Adjudicated MACE at 30 days (time frame: 30 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 30 Oct 2009; AzTrials last refreshed its copy on 6 Nov 2026.