Status:
COMPLETED
Per-cutaneous Intervention Based Paclitaxel and Sirolimus-Eluting Versus Bare Stents for the Treatment of de Novo Coronary Lesions (PAINT)
Lead Sponsor:
Sahajanand Medical Technologies Limited
Collaborating Sponsors:
CMS Medical
Conditions:
Coronary Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Objectives: PRIMARY OBJECTIVE: To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents. SECONDARY OBJECTIVES: Saf...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia;
- De novo coronary lesion (non-restenosis);
- Target lesion located in a native artery;
- Target lesion located in a vessel with diameter between 2.5-3.5 mm (visual analysis);
- Target lesion amenable to treatment with a single stent of up to 29 mm in length;
- Target lesion with a diameter stenosis \> 50% (visual analysis);
- Acceptable candidate for surgical revascularization;
- Signed informed consent term.
Exclusion
- GENERAL EXCLUSION CRITERIA
- Q-wave myocardial infarction \< 48 hours before the index procedure
- Recent myocardial infarction, with or without Q waves, with cardiac markers levels still above the normal upper limits
- Left ventricle ejection fraction ≤30%
- Renal dysfunction (serum creatinine \> 2.0 mg/dl \[\>177 µmol/l\])
- Platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3
- White cell count \< 3.000 cells/mm3
- Suspected or known liver disease (including subclinical hepatitis)
- Heart transplant recipient
- Know allergy to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin, or stainless steel
- Life expectancy \< 12 months
- Any medical condition that, in the opinion of the investigator, may interfere with the ideal participation in study
- 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.
- Coronary angioplasty (with or without stent) \< 6 months in any segment of the target vessel
- Previous coronary angioplasty (with or without stent), at any time, in a coronary segment \< 5 mm (proximal or distal) from the target lesion
- 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
- Restenotic target lesion
- Need for treatment of more than one lesion in the target vessel;
- Diameter of the target vessel \< 2.5 mm or \> 3.5 mm (visual analysis)
- Long target lesion, not amenable to treatment with a single stent of up to 29 mm in length, according to the operator's discretion
- Significant (\> 50%) unprotected left main lesion
- Angiographic thrombus
- Target lesion located in bypass graft
- Occluded target vessel (antegrade flow TIMI 0 or 1)
- Target lesion in ostial location;
- Target lesion in a bifurcation site with a side branch \> 2.5 mm or that may require stent implantation;
- Calcified target lesion with anticipated unsuccessful balloon pre-dilatation;
- Severely tortuous target vessel.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00752362
Start Date
March 1 2006
Last Update
November 20 2015
Active Locations (11)
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1
Hospital Universitário Walter Cantídio
Fortaleza, Ceará, Brazil, 60430-370
2
Hospital Universitário Cassiano Antonio de Moraes
Vitória, Espírito Santo, Brazil, 29042-755
3
Hospital Meridional Intercath
Vitória, Espírito Santo, Brazil, 29156-580
4
Hospital Biocor
Belo Horizonte, Minas Gerais, Brazil, 34000-000