Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)

This is an interventional treatment trial for Coronary Artery Disease Read More

Inclusion Criteria:

General 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.

Angiographic Inclusion Criteria

1. Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;

2. 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:

   1. Residual diameter stenosis < 30%;
   2. Absence of any angiographic complications;
   3. Absence of ischemic symptoms; and
   4. Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischemia.
3. Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate;
4. Target lesion < 20 mm in length by visual estimate (the intention is to cover the entire lesion with one stent of adequate length); and
5. Target lesion stenosis ≥ 50% and < 100% by visual estimate.

Exclusion Criteria:

General 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:

   1. 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;
   2. 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) ≤ 30%;
11. Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);
12. Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate, Ticlopidine, Prasugrel, Rapamycin, Zotarolimus, PEAIII AcBz, Heparin/ Bivalirudin, or contrast agent (that cannot be adequately premedicated);
13. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3.000 cells/mm3 or hemoglobin < 100g/l;
14. Acute or chronic renal dysfunction (serum creatinine > 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.

Angiographic Exclusion Criteria

1. Total occlusion (TIMI 0 or 1);
2. Target vessel has angiographic evidence of thrombus
3. Target vessel is excessively tortuous or has heavy calcification;
4. Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
5. Target lesion is located in or supplied by an arterial or venous bypass graft;
6. Ostial target lesion (within 5.0 mm of vessel origin) or any location within the left main coronary artery;
7. Target lesion involves a side branch > 2.0 mm in diameter; and
8. Unprotected Left Main coronary disease (stenosis > 50%).