Per-cutaneous Intervention Based Paclitaxel and Sirolimus-Eluting Versus Bare Stents for the Treatment of de Novo Coronary Lesions (PAINT)

This is an interventional treatment trial for Coronary Restenosis focused on measuring Supralimus®,, Infinnium®,, Matrix®,, Restenosis, Percutaneous, Revascularization, Techniques, Metallic, Platform, Agents, Antiproliferative, Properties Read More

Inclusion Criteria:

1. Age ≥ 18 years;
2. Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia;
3. De novo coronary lesion (non-restenosis);
4. Target lesion located in a native artery;
5. Target lesion located in a vessel with diameter between 2.5-3.5 mm (visual analysis);
6. Target lesion amenable to treatment with a single stent of up to 29 mm in length;
7. Target lesion with a diameter stenosis > 50% (visual analysis);
8. Acceptable candidate for surgical revascularization;
9. Signed informed consent term.

Exclusion Criteria:

GENERAL EXCLUSION CRITERIA

1. Q-wave myocardial infarction < 48 hours before the index procedure
2. Recent myocardial infarction, with or without Q waves, with cardiac markers levels still above the normal upper limits
3. Left ventricle ejection fraction ≤30%
4. Renal dysfunction (serum creatinine > 2.0 mg/dl [>177 µmol/l])
5. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3
6. White cell count < 3.000 cells/mm3
7. Suspected or known liver disease (including subclinical hepatitis)
8. Heart transplant recipient
9. Know allergy to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin, or stainless steel
10. Life expectancy < 12 months
11. Any medical condition that, in the opinion of the investigator, may interfere with the ideal participation in study
12. Current inclusion in another study to investigate drug or other device, or planned inclusion in another study to investigate drug or other device during the follow-up.
13. Coronary angioplasty (with or without stent) < 6 months in any segment of the target vessel
14. Previous coronary angioplasty (with or without stent), at any time, in a coronary segment < 5 mm (proximal or distal) from the target lesion
15. Coronary angioplasty (with or without stent) in any segment of the target vessel planned during the next 12 months following the index procedure.

ANGIOGRAPHIC EXCLUSION CRITERIA

1. Restenotic target lesion
2. Need for treatment of more than one lesion in the target vessel;
3. Diameter of the target vessel < 2.5 mm or > 3.5 mm (visual analysis)
4. Long target lesion, not amenable to treatment with a single stent of up to 29 mm in length, according to the operator's discretion
5. Significant (> 50%) unprotected left main lesion
6. Angiographic thrombus
7. Target lesion located in bypass graft
8. Occluded target vessel (antegrade flow TIMI 0 or 1)
9. Target lesion in ostial location;
10. Target lesion in a bifurcation site with a side branch > 2.5 mm or that may require stent implantation;
11. Calcified target lesion with anticipated unsuccessful balloon pre-dilatation;
12. Severely tortuous target vessel.