CoStar Catheter System Evaluation (CONCISE)

This study has been terminated.
(CoStar Stent IDE failed to meet primary endpoint)
Sponsor:
Information provided by:
Conor Medsystems
ClinicalTrials.gov Identifier:
NCT00993785
First received: October 9, 2009
Last updated: October 27, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Symptomatic Ischemic Heart Disease
Device: Costar Coronary Stent Delivery System
Phase 3

Study Type: Interventional

Further study details as provided by Conor Medsystems:

Enrollment: 58
Study Start Date: February 2007
Study Completion Date: April 2008
Arms Assigned Interventions
Experimental: OTW Catheter System Device: Costar Coronary Stent Delivery System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993785

Locations
Germany
Herz-Kreislauf-Zentrum
Am Kurpark 1, Segeberger Kliniken GmbH, Germany, 23795
Sponsors and Collaborators
Conor Medsystems
  More Information

No publications provided

Responsible Party: Sid Cohen, M.D., Cordis
ClinicalTrials.gov Identifier: NCT00993785     History of Changes
Other Study ID Numbers: CP-04
Study First Received: October 9, 2009
Last Updated: October 27, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014