A Prospective, Single Blinded, Randomized Study to Evaluate the Safety and Effictiveness of a Low and Standard Dose Biolimus A9TM Drug-Eluteing Coronary Stent Delivery System Compared With a TaxusTM LiberteTM Control Arm for Treatment of Stenotic Lesions in Native Coronary Arteries.

Biosensors Europe SA4 sites in 1 country182 target enrollmentAugust 2008

ConditionsTreatment Of Stenotic Lesions In Native Coronary Arteries.

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Treatment Of Stenotic Lesions In Native Coronary Arteries.
Sponsor: Biosensors Europe SA
Enrollment: 182
Locations: 4
Primary Endpoint: In-Stent Late Lumen Loss at 12 months post-procedure.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the Taxus Liberte DES in the treatment of single de novo native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.0 mm and ≤ 14 mm in length.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biosensors Europe SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject is \>18 years of age.
•The subject is an acceptable candidate for PTCA, stenting, and emergent CABG.
•Patients with multiple lesions as long as the last lesion to be treated fits the Inclusion criteria of the target lesion.
•The subject must have clinical evidence of ischemic heart disease or a positive functional study.
•The study stent target vessel must be a native coronary artery with a stenosis of \>50% and \<100%.
•The study stent target vessel reference diameter must be \>2.5 mm and ≤ 3.0 mm.(Measurements may be made by careful visual estimate or on-line quantitative coronary angiography.)
•The study stent target lesion is a de novo lesion that has not been previously stented.
•The study stent target lesion must be ≤ 14 mm in length thus allowing for adequate lesion coverage with a single stent.
•The subject is male or, if female, is either not of childbearing potential or has had a negative pregnancy test within seven (7) days prior to the procedure.
•The subject or the subject's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee (IEC) of the clinical site.

Exclusion Criteria

•Multiple lesions to be treated in the same target vessel.
•Patients who require more than one BioFreedom stent except that an additional BioFreedom stent may be implanted in the target lesion for geographic miss or bailout
•A documented left ventricular ejection fraction \< 30% assessed within 6 months prior to procedure by echocardiography, during a previous angiography or as measured during pre-procedure angiography.
•A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine and, clopidogrel, stainless steel, Biolimus A9, Paclitaxel or a sensitivity to contrast media, which cannot be adequately pre-medicated.
•A platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³, or a WBC \<3,000 cells/mm³.
•Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave infarction having CK enzymes \> 2 times the upper laboratory normal with the presence of a CK-MB elevated above the institutions upper limit of normal).
•A previous coronary interventional procedure was performed either a.) within 24 hours prior to the procedure or b.) within 12 months prior to the procedure for any lesion in the target vessel.
•The subject requires planned interventional treatment of any lesion in either the target vessel within 12 months or in any non-target vessel within 30 days post-procedure.
•The target and non-target lesion require treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
•The target vessel has angiographic evidence of thrombus or is excessively (2 bends \> 90º to reach the target lesion) tortuous.

Outcomes

Primary Outcomes

In-Stent Late Lumen Loss at 12 months post-procedure.

Time Frame: 12 Months

Secondary Outcomes

In-Stent Late Lumen Loss (LL) at 4 months post-procedure for patients receiving IVUS/Angio at 4 months(4 months)
2. Major adverse cardiac events (MACE) at 30 days, defined as death, myocardial infarction or ischemic target vessel revascularization (PCI or CABG).(30 days)
3. Major Adverse Cardiac Event (MACE) at hospital discharge, 30 days, 4 months, 12 months, and 2, 3, 4 and 5 years post-procedure.(5 years)
Vascular complications through hospital discharge.(5 years)
5. Rates of stent thrombosis, per ARC definition of definite and probable and categorized as early, late or very late, at 30 days, 4 and 12 months, 2, 3, 4 and 5 years post-procedure.(5 years)
6. Biolimus A9 drug systemic drug levels post-procedure, 4 hours post-procedure, at hospital discharge, and at 30 days and 4 months clinical follow-up.(4 months)