Evaluation of a New Nanotechnology Based Drug-Eluting Stent for Opening of Narrowed Arteries of the Heart

This is an interventional treatment trial for Coronary Stenosis focused on measuring coronary stenting, drug eluting stents, paclitaxel, nanoporous Read More

Inclusion Criteria:

1. Male or non-pregnant female 2: 18 years of age (note: females of child bearing potential must have a negative pregnancy test within 7 days of treatment and must use effective pregnancy avoidance until the 6 month angiogram is completed)
2. Have chest pain consistent with angina pectoris or a history of documented myocardial infarction or documented silent ischemia
3. Treatment of a native vessel de novo coronary lesion (only 1 single study lesion/patient)
4. Target vesseI2.5mm-4.0mm in diameter (visual estimate)
5. Target lesion length::: 12mm (visual estimate)
6. Target lesion stenosis> 50% and < 100% (visual estimate)
7. At least TIMI grade II coronary flow
8. Acceptable candidate for CABG surgery
9. Patient is willing to come back for a follow-up evaluations including repeat cardiac catheterization 5-7 months after treatment
10. Patient must provide written informed consent prior to the index procedure using a form that is approved by the local Ethics Committee

Exclusion Criteria:

1. Patient has experienced an acute myocardial infarction (Q wave or non-Q wave) within 72 hours prior to the index procedure with CK enzymes 2: 2x the local laboratory upper limit of normal, with the presence of CK- MB levels elevated above the local laboratory upper limit of normal;
2. Unprotected left main coronary disease with> 50% stenosis;
3. Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede runoff;
4. Ostial location of the target lesion;
5. Angiographic evidence of thrombus within the target lesion;
6. Severely calcified'lesion which cannot be successfully predilated;
7. Documented L VEF < 25%, or clinically significant congestive cardiac failure;
8. Totally occluded vessel;
9. Impaired renal function (creatinine> 0.27mmol/L) at the time of treatment;
10. Pretreatment with devices other than balloon angioplasty;
11. Excessive tortuosity proximal to the lesion which makes stent delivery and deployment uncertain;
12. Target lesion involves a bifurcation including a diseased side branch> 2.5mm in diameter that would require treatment;
13. Prior stenting within 5mm of the target lesion;
14. Patient is a recipient of a heart transplant;
15. Patient has a life expectancy < 12 months;
16. Known allergies to clopidogrel bisulfate (Plavix@), ticlopidine (Ticlid@), Cobalt Chromium alloy and Paclitaxol that cannot be medically managed;
17. In the investigator's opinion, any significant medical condition which may interfere with the patient's optimal participation in this study;
18. Currently participating in an investigational drug or device study that has not completed the primary endpoint;
19. Intervention of another coronary lesion has occurred within 30 days before or is planned within 30 days after the index procedure.
20. In the investigator's opinion, the lesion is not suitable for stenting