CoStar Catheter System Evaluation (CONCISE)

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

Study Overview

• Status: Terminated
• Conditions: Symptomatic Ischemic Heart Disease
• Intervention / Treatment: Device: Costar Coronary Stent Delivery System

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Segeberger Kliniken GmbH
    • Am Kurpark 1, Segeberger Kliniken GmbH, Germany, 23795
      • Herz-Kreislauf-Zentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is ≥18 years of age.
2. Eligible for percutaneous coronary intervention (PCI).
3. Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification [CCS] 1, 2, 3, or 4), documented ischemia, or documented silent ischemia.
4. Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks.
5. Acceptable candidate for coronary artery bypass graft surgery (CABG).
6. 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.
7. Willing to comply with all specified follow-up evaluations.

Inclusion Criteria (Angiographic):

1. A single de novo lesion per study subject may be treated with the study device.
2. Each target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent.
3. Cumulative target lesion length per vessel is ≤24 mm based on a visual estimate.
4. RVD of ≥2.5 mm to ≤3.0 mm based on a visual estimate.
5. Target lesion diameter stenosis ≥50% and <100% based on a visual estimate.
6. Target vessel has not undergone prior revascularization within the preceding 6 months.
7. Target lesion must be a minimum of 10 mm distance from any previously treated segment of the target vessel

Exclusion Criteria:

1. Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: PLGA.
2. Planned treatment with any other PCI device in the target vessel(s).
3. 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.
4. The patient is in cardiogenic shock.
5. Cerebrovascular Accident (CVA) within the past 6 months.
6. Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/L).
7. Contraindication to ASA or to clopidogrel.
8. Thrombocytopenia (platelet count <100, 000/mm3).
9. Active gastrointestinal (GI) bleeding within the past three months.
10. Any prior true anaphylactic reaction to contrast agents.

Study Plan

How is the study designed?

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OTW Catheter System	Device: Costar Coronary Stent Delivery System

Collaborators and Investigators

• Sponsor: Conor Medsystems

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: October 9, 2009
• First Submitted That Met QC Criteria: October 9, 2009
• First Posted (Estimate): October 12, 2009

Study Record Updates

• Last Update Posted (Estimate): October 29, 2009
• Last Update Submitted That Met QC Criteria: October 27, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: CP-04