CoStar™ Paclitaxel-Eluting Coronary Stent Catheter System Evaluation

Conor Medsystems

Status and phase

Completed

Phase 3

Conditions

Coronary Disease

Treatments

Device: CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT00422435

The PreCiSE Trial: CP-03

Details and patient eligibility

About

This study is designed to evaluate the performance and safety of a new catheter system.

Full description

This study is designed to evaluate acute Device Success, defined as attainment of <50% residual stenosis of the target lesion.

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient ≥18 years of age
Eligible for percutaneous coronary intervention
Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification 1, 2, 3, or 4), documented ischemia, or documented silent ischemia
Left ventricular ejection fraction ≥25% documented within the last 6 wks
Acceptable candidate for coronary artery bypass graft surgery
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 1 study stent
Cumulative target lesion length per vessel ≤30 mm based on a visual estimate
RVD ≥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 10 mm distance from any previously treated segment of the target vessel

Exclusion criteria

Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: Translute or PLGA
Planned treatment with any other PCI device in the target vessel(s)
MI within 72 hours prior to the index procedure
Patient is in cardiogenic shock
Cerebrovascular Accident 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 bleeding within the past three months
Any prior true anaphylactic reaction to contrast agents
Patient is currently, or has been treated with paclitaxel (systemic) within 12 months of the index procedure
Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the study
Life expectancy of less than 24 months due to other medical conditions
Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
Left main coronary artery disease (stenosis >50%), whether protected or unprotected
Target lesion is ostial in location (within 3.0 mm of vessel origin)
Target lesion and/or target vessel proximal to the target lesion is severely calcified by visual estimation
Target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter that requires intervention
Target lesion is totally occluded Thrombolysis In MI (TIMI flow ≤1)
Angiographic presence of probable or definite thrombus
Target vessel will be pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
Prior coronary intervention using brachytherapy to any segment of the target vessel
The target vessel has had prior drug-eluting stent placement to vessel segment (or branch) proximal to intended target lesion site
Angiographic restenosis of any segment of the target vessel that has undergone prior percutaneous coronary intervention
Angiographic evidence of atherosclerotic disease with > 50% diameter stenosis (by visual estimate) proximal or distal to the target lesion (applies to the major epicardial portion of the target vessel and contiguous vessel segment if the target lesion is located in a branch vessel)
Prior surgical revascularization of the target vessel with patent graft (saphenous vein graft or arterial conduit)
Target lesion lies within 10 mm of prior surgical anastomosis site