Prospective, Multi-Center, Random. Study of CoStar Paclitaxel-Eluting Coronary Stent(Direct Stenting vs. Pre-Dilatation) (DECIDE)
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ClinicalTrials.gov Identifier: NCT00440674 |
Recruitment Status
:
Terminated
First Posted
: February 27, 2007
Last Update Posted
: October 30, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Device: CoStar Paclitaxel-eluting coronary stent system | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Direct stenting technique
|
Device: CoStar Paclitaxel-eluting coronary stent system |
Experimental: 2
Conventional stenting with pre-dilatation strategy
|
Device: CoStar Paclitaxel-eluting coronary stent system |
- Adjudicated MACE at 30 days [ Time Frame: 30 days ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440674
Germany | |
Universitäres Herz-und Gefäßzentrum Hamburg | |
Hamburg, Germany, D-22527 |
Principal Investigator: | Joachim Schofer | Universitäres Herz-und Gefäßzentrum Hamburg |
Responsible Party: | Joachim Schofer, Principal Investigator, Universitäres Herz-und Gefäßzentrum Hamburg |
ClinicalTrials.gov Identifier: | NCT00440674 History of Changes |
Other Study ID Numbers: |
The DECIDE Trial: CP-05 |
First Posted: | February 27, 2007 Key Record Dates |
Last Update Posted: | October 30, 2009 |
Last Verified: | October 2009 |
Keywords provided by Conor Medsystems:
Direct Stenting Angioplasty Pre-dilatation Drug-eluting stent |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Aneurysm Dilatation, Pathologic Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Pathological Conditions, Anatomical Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |