Status:
TERMINATED
CoStar Catheter System Evaluation
Lead Sponsor:
Conor Medsystems
Conditions:
Symptomatic Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion.
Eligibility Criteria
Inclusion
- 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.
- Willing to comply with all specified follow-up evaluations.
- Inclusion Criteria (Angiographic):
- 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
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00993785
Start Date
February 1 2007
End Date
April 1 2008
Last Update
October 29 2009
Active Locations (1)
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1
Herz-Kreislauf-Zentrum
Am Kurpark 1, Segeberger Kliniken GmbH, Germany, 23795