Status:
COMPLETED
Cortisone or Drug Eluting Stents (DES) as Compared to Bare Metal Stents (BMS) to EliminAte Restenosis
Lead Sponsor:
Universita di Verona
Collaborating Sponsors:
Regione Piemonte
Conditions:
Coronary Artery Disease
Ischemic Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The possibility of using the new drug eluting stents (DES) technology has significantly changed the mid-term outcome of percutaneous coronary interventions (PCI) in terms of reduced recurrence of angi...
Detailed Description
Design of the study It is very important to underline that this is a "spontaneous" study, i.e. not receiving sponsorship from pharmaceutical industries, stent manufacturers, or any other financial so...
Eligibility Criteria
Inclusion
- Patients with diagnosed CAD (either SVD or MVD) with signs or symptoms of myocardial ischemia, scheduled for percutaneous revascularization are all candidates.
- Either native vessels and SVG can be included with de-novo or recurrent lesions.
- Lesions causing a diameter stenosis \>50% in a main coronary artery (LAD, RCA, LCx) or their principal branches (Dg, OM, PL, PDA).
Exclusion
- Diabetes
- Age over 80 years old
- Recent Q wave myocardial infarction (less than 2 weeks)
- Severe hypertension, uncontrolled despite medical treatment
- Gastric ulcer or symptomatic gastritis
- Neoplasia
- Renal failure (creatinine \>2.5)
- Left main disease, or left main equivalent (proximal LAD and proximal LCx), or three vessel disease involving the proximal segments of the 3 main coronary branches
- Suboptimal angiographic result of PCI (DS% \>30% or TIMI flow \<grade 3)
- Contraindications to high-doses of steroids (immunosuppression, active infective disease, osteoporosis, recent use of high doses of steroids).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00369356
Start Date
October 1 2006
End Date
January 1 2011
Last Update
January 23 2013
Active Locations (5)
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1
Istituto Clinico Humanitas
Milan, Milano, Italy, 20089
2
Ospedale Maggiore della Carità
Novara, Novara, Italy, 28100
3
European Hospital
Rome, Rome, Italy, 00149
4
Ospedale San Giovanni Bosco
Torino, Torino, Italy, 10100