Evaluating the Svelte Drug Eluting Stent-on-a-Wire (DESOAW) in Patients with Symptomatic Ischemic Heart Disease due to Coronary Artery Blockage

Svelte Medical Systems, Inc.0 sites30 target enrollmentOctober 28, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 28, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Patient is at least 18 years old;
•2\. Patient is eligible for percutaneous coronary intervention (PCI) and an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;
•3\. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study;
•4\. Patient has either a single target lesion, or two lesions (target and non\-target) located in separate coronary arteries;
•5\. Reference vessel of 2\.5 mm through 3\.5 mm in diameter by visual estimate;
•6\. Target lesion less than 20 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length);
•7\. Target lesion stenosis between 50% and 100% by visual estimate.

•1\. Patient is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
•2\. The patient requires a staged procedure of the target vessel within 6 months or a staged procedure of a non\-target vessel within 30 days post\-procedure;
•3\. The target lesion requires 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.);
•4\. Any DES deployment anywhere in the target vessel within the past 9 months;
•5\. Any BMS deployment anywhere in the target vessel within the past 6 months;
•6\. Any previous stent placement within 10 mm (proximal or distal) of the target lesion;
•7\. Myocardial infarction within 72 hours of the index procedure, with the exception of:
•a. Patients who have had a STEMI and PCI to the culprit lesion may be included if they have a suitable lesion in another vessel, and have been clinically and hemodynamically stable for 72 hours;
•b. Patients who have had a non\- STEMI may be included if their CK is within the laboratory normal range within 24 hours pre\-procedure.
•8\. Co\-morbid condition(s) that could limit the patient’s ability to participate in the trial or to comply with follow\-up requirements, or impact the scientific integrity of the trial;