Status:
UNKNOWN
The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients
Lead Sponsor:
Hospital Universitario Infanta Cristina
Conditions:
Diabetes Mellitus
Percutaneous Coronary Intervention
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
Even though the safety of drug eluting stents has been long established, in roughly 25% o patients their implantation is not considered, for specifically clinical reasons (chronic anticoagulation, ble...
Eligibility Criteria
Inclusion
- Age over 18 years
- Diabetes mellitus according to the World Health Organization Report
- Percutaneous coronary intervention due to at least one significant de novo lesion (defined as at least 50% diameter stenosis by visual estimation) in a native coronary artery or coronary bypass graft.
- Informed Consent "signed"
Exclusion
- Inclusion in another clinical research protocol
- Pregnancy
- STEMI within 48 hours
- Unprotected left main disease
- Restenotic lesions
- Stent diameter \< 2,5 mm or \> 3,5 mm
- Stent length more than 28 mm in \< 3 mm vessels
- Chronic total occlusions
- Allergy to aspirin, clopidogrel, heparin or abciximab
- Active bleeding or a significant increase in bleeding risk
- Significant renal insufficiency defined as creatinine \> 2 mg/dl
- Severely depressed LV function (EF≤35%)
- Cardiogenic shock
- Ischemic stroke within the last 6 months
- Contraindication for DES
- Disease with life expectancy \< 12 months
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01510509
Start Date
January 1 2009
Last Update
January 16 2012
Active Locations (8)
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1
Heart Center, Satakunta Hospital, Pori, Finland
Satakunta, Pori, Finland, 28500
2
Hospital de Torrevieja
Torrevieja, Alicante, Spain, 03180
3
Hospital Universitario Infanta Cristina
Badajoz, Badajoz, Spain, 06006
4
Hospital Puerto Real de Cádiz
Puerto Real, Cadiz, Spain, 11510