CoStar Catheter System Evaluation

NCT00993785 | Terminated Phase 3

• 1 other identifier: CP-04
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion.

Conditions

Symptomatic Ischemic Heart Disease

Study Arms (1)

OTW Catheter System

EXPERIMENTAL

Device: Costar Coronary Stent Delivery System

Interventions

Costar Coronary Stent Delivery System DEVICE

OTW Catheter System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Conor Medsystems: lead

Study Sites (1)

Herz-Kreislauf-Zentrum

Am Kurpark 1, Segeberger Kliniken GmbH, 23795, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 12, 2009
• Study Start: February 1, 2007
• Study Completion: April 1, 2008
• Last Updated: October 29, 2009

Record last verified: 2009-10

Locations

DE (1)