The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent (BIOHELIX-II) - BIOHELIX-II

Biotronik0 sites18 target enrollmentTBD

Conditionscoronary artery diease coronary lesions 10011082

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: coronary artery diease
Sponsor: Biotronik
Enrollment: 18
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

October 31, 2014

Last Updated

2 years ago

Study Type

Observational invasive

Investigators

Sponsor

Biotronik

Eligibility Criteria

Inclusion Criteria

•For a subject to be enrolled in the study and considered for the index procedure, the following initial inclusion criteria must be met:
•Age \* 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:
•De novo or restenotic lesion in a native coronary artery; restenotic lesions must have been previously treated with only standard PTCA (treatment must be \> 12 months prior to the index procedure)

Exclusion Criteria

•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
•Intolerance to contrast agents that cannot be medically managed and/or intolerance to antiplatelet, anticoagulant or thrombolytic medications
•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
•Participation in any other clinical investigational device or drug study. Subjects may be concurrently enrolled in a post\-market study, as long as the post\-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.;For a subject to receive an investigational stent the following procedure\-related criteria must not be present:
•Concomitant renal failure with serum creatinine level \> 2\.5 mg/dL