coronary artery stenosis - narrowing of the coronary artery
Conditions
Interventions
Angiography and coronary angioplasty.
Sponsors
Svelte Medical Systems, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Patient is >=18 years old; 2.Patient is eligible for percutaneous coronary intervention (PCI); 3.Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery; 4.Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study; 5.Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure; 6.Patient or subject*s legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site; and 7.Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed. 8.Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries; 9.If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met: a.Residual diameter stenosis = 2.5 mm and = 50% and
Exclusion criteria
Exclusion criteria: 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 Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials; 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 troponin levels are 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; 9.Concurrent medical condition with a life expectancy of less than 12-months; 10.Documented left ventricular ejection fraction (LVEF) 700,000 cells/mm3 or a WBC 170µmol/L); 15.History of a stroke or transient ischemic attack (TIA) within the prior 6-months; 16.Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6-months; 17.History of bleeding diathesis or coagulopathy or will refuse blood transfusions; and 18.Patients requiring ongoing anticoagulation with warfarin or dabigatran. 19.Total occlusion (TIMI 0 or 1); 20.Target vessel has angiographic evidence of thrombus 21.Target vessel is excessively tortuous or has heavy calcification; 22.Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off; 23.Target lesion is located in or supplied by an arterial or venous bypass graft; 24.Ostial target lesion (within 5.0 mm of vessel origin) or any location within the left main coronary artery; 25.Target lesion involves a side branch > 2.0 mm in diameter; and 26.Unprotected Left Main coronary disease (stenosis > 50%).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint is angiographic Target Vessel Failure (TVF) at 6-months post-procedure; the primary efficacy endpoint is angiographic in-stent Late lumen Loss (LL) at 6-months post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: •Clinically-driven Target Lesion Revascularization (TLR) at 1 and 6-months and yearly through 5-years post-procedure; •Composite of cardiac death, MI attributed to the target vessel and clinically driven TLR at 1 and 6-months post-procedure and yearly up to 5-years; •Composite of all-cause mortality, any MI and any revascularization, TVR or revascularization of non-target vessels at 5-years post-procedure; •Stent thrombosis at 1 and 6-months and yearly for 5-years post-procedure; •Acute success rates: -Device Success: Attainment of | — |
Countries
Netherlands
Outcome results
None listed