The treatment of coronary artery lesions using the PRO-Kinetic energy cobalt-chromium, bare-metal stent (BIOHELIX-I) - BIOHELIX-I

Biotronik0 sites17 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 19, 2017

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•For a subject to be enrolled in the study and considered for the index procedure, the following initial inclusion criteria must be met:
•\* Age \> or \<\= 18 years
•\* Willingness to comply with study follow\-up requirements
•\* Candidate for a PCI procedure
•\* Candidate for coronary artery bypass graft surgery
•\* Documented evidence of stable or unstable angina pectoris or positive functional ischemia study (e.g. exercise treadmill test, thallium stress test, SPECT, stress echocardiogram or cardiac CT)
•\* Stable angina pectoris is defined as a documented Canadian Cardiovascular Society Classification of I, II, III or IV
•\* Unstable angina pectoris is defined as a documented Braunwald Classification of B \& C, I, II, III
•\* Written informed consent
•For a subject to receive an investigational stent, the following procedure\-related criteria must be met:

•For a subject to be enrolled in the study and considered for the index procedure, the following initial exclusion criteria must not be present:
•\* Baseline LVEF of \< 30%; LVEF may be measured and assessed by standard\-of\-care echocardiography procedures within 90 days of the index procedure or by a left ventriculogram prior to the index procedure (operator visual assessment)
•\* PCI in any vessel 30 days prior to the index procedure or planned for within 30 days after the index procedure
•\* Stroke or transient ischemic attack within the last 6 months prior to enrollment
•\* Intolerance to contrast agents that cannot be medically managed and/or intolerance to antiplatelet, anticoagulant or thrombolytic medications
•\* Refusal of blood transfusions
•\* Any other medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications
•\* Pregnant, planning to become pregnant or nursing during the course of the study. Women of child\-bearing potential must have a negative blood pregnancy (beta hCG) test. Female subjects who are surgically sterile or post\-menopausal are exempt from having a pregnancy test.
•\* Known allergy to L\-605 CoCr alloy (cobalt, chromium, tungsten and nickel) or amorphous silicon carbide
•\* Life expectancy of less than one year