Back to resultsCoStar Catheter System Evaluation (CONCISE)
Primary Purpose
Symptomatic Ischemic Heart Disease
Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Costar Coronary Stent Delivery System
Sponsored by
About this trial
This is an interventional trial for Symptomatic Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Herz-Kreislauf-Zentrum
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OTW Catheter System
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00993785
Brief Title
CoStar Catheter System Evaluation
Acronym
CONCISE
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
CoStar Stent IDE failed to meet primary endpoint
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Conor Medsystems
4. Oversight
5. Study Description
Brief Summary
To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Ischemic Heart Disease
7. Study Design
Study Phase
Phase 3
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTW Catheter System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Costar Coronary Stent Delivery System
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
Herz-Kreislauf-Zentrum
City
Am Kurpark 1
State/Province
Segeberger Kliniken GmbH
ZIP/Postal Code
23795
Country
Germany
12. IPD Sharing Statement
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CoStar Catheter System Evaluation
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