Clinical Evaluation of the Momo Cobalt-Chromium Coronary Stent System for the Treatment of Patients With Coronary Artery Disease

be Medical6 sites in 1 country100 target enrollmentFebruary 2012

ConditionsCoronary Artery Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: be Medical
Enrollment: 100
Locations: 6
Primary Endpoint: 6-month angiography
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study evaluates the safety and effectiveness of the Momo Cobalt Chromium stent system for the treatment of single de novo lesions in a native coronary artery. The stent is coated with diamond-like carbon to decrease the risk of acute and late stent thrombosis, to increase the resistance towards corrosion and to significantly improve endothelialisation through the inhibition of elution of metallic ions.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

July 2013

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

be Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with stable angina pectoris (Canadian Cardiovascular Society \[CCS\] I to IV) or unstable angina pectoris (Braunwald classification IB-C, IIB-C or IIIB-C) or patients with documented silent ischemia.
•Patients who are eligible for coronary revascularization by angioplasty and stenting and by CABG (if required as bail-out).
•Patients with a de novo lesion in a native coronary artery between \> 50 % and \< 100 % stenosis.
•One or two heart vessel disease with a maximum of 2 lesions to be treated by stenting.
•Both lesions have to be treated with study stents.
•Target vessel suitable for implantation of a single stent with a target vessel diameter of ≥ 2.5 mm and lesion length \< 20 mm.
•Patients with left ventricular ejection fraction (LVEF) of \> 30 %.
•Patients willing to sign a written informed consent prior to participation and willing to be compliant with all requested follow-up evaluations.

Exclusion Criteria

•Patients under the age of 18 or unable to give informed consent.
•Women of child bearing potential.
•Patients who currently participate in another study (whatever the subject of that study is).
•Patients who participated in another investigational cardiovascular drug or device study, which have not completed the primary endpoint follow-up period within the past 30 days.
•Patients with a life expectancy of less than 24 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.).
•Patients who intend to have a major (as per principal investigators' medical judgment) surgical intervention within 6 months of enrolment in the study.
•Patients with an episode of sustained ischemic chest pain exceeding 15 minutes duration within 24 hours prior to stenting or patients with new ST elevation within 48 hours prior to stenting.
•Patients with a contraindication to emergency coronary bypass surgery.
•Any individual who may refuse a blood transfusion.
•Patients with serum creatinine \> 2.0 mg/dl or (\> 180 µmol/l).