Status:
COMPLETED
Safety and Effectiveness Study of Combo Bio-engineered Sirolimus Eluting Stent
Lead Sponsor:
OrbusNeich
Conditions:
Coronary Artery Lesions
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery lesions.
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- The patient must be ≥18 and ≤ 80 years of age;
- Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or objective evidence of myocardial ischemia);
- Acceptable candidate for CABG;
- The Patient is willing to comply with specified follow-up evaluations;
- The Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC).
- Angiographic
- Single de novo or non-stented restenotic lesion in the target vessel;
- Patients with two-vessel coronary disease, may have undergone successful treatment (\<20% diameter stenosis by visual estimate) of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment. Any non-target vessel or lesion intended to be treated during the index procedure, cannot be an unprotected left main, ostial lesion, chronic total occlusion (CTO), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty;
- Target lesion located in a native coronary artery;
- Target lesion (maximum length is 20 mm by visual estimate) covered by a single stent maximum 23 mm length for Combo Stent, and 24 mm in length for TAXUS® Liberté® (stent coverage including at least 3 mm of healthy vessel is recommended). The lesion length should be measured after pre-dilation procedure;
- Reference vessel diameter must be ≥2.5 to ≤ 3.5 mm by visual estimate. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected;
- Target lesion ≥50% and \<100% stenosed by visual estimate.
Exclusion
- General
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00967902
Start Date
November 1 2009
End Date
September 1 2015
Last Update
March 29 2016
Active Locations (1)
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1
John Hunter Hospital
Newcastle, New South Wales, Australia, 2300