An Observational Safety Evaluation of patients treated with the NEVO* Sirolimus-eluting Coronary Stent.

Completed

Conditions: Coronary Artery Lesions. Ischemia (lack of O2) in the heart muscle due to atherosclerosis/cholesterol
10011082

Registration Number: NL-OMON36595

Lead Sponsor: Johnson & Johnson

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Subject has atherosclerotic coronary artery disease with an indication for stent implantation;
2. Target lesion(s) with a diameter stenosis of minimally 50% (visual estimate) OR a functional study documenting the hemodynamic relevance of the target lesion(s);
3. All target lesion(s) require treatment with stents having diameters from 2.5mm to 3.5mm (visual estimate);
4. Subject is >=18 years of age;
5. Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure;
6. Subject must be willing and able to comply with specified follow-up schedule.

Exclusion Criteria

1. Planned medical procedures or concomitant disease requiring modification of DAPT regimen within 6 months of enrollment into this study;
2. Women of childbearing potential without negative pregnancy test within 7 days before enrollment OR women who do not agree to remain on birth control until angiographic follow-up at 13 months if applicable OR lactating women. For women of childbearing potential, requiring an acute, non-elective procedure, a verbal confirmation of non pregnancy and birth control is sufficient;
3. Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Twelve month composite clinical endpoint of all death, all MI and all<br /><br>revascularizations.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Measured as defined in the protocol:<br /><br><br /><br>- Composite endpoint of all death, all MI and all revascularizations and its<br /><br>individual components.<br /><br><br /><br>- Stent thrombosis defined as definite, probable, possible and composite of<br /><br>definite and probable at early, late and very late time points (using ARC<br /><br>definition)<br /><br><br /><br>- Bleeding complication<br /><br><br /><br>- Stroke<br /><br><br /><br>- Device, Procedural and Lesion Success</p><br>