Coronary Artery Disease
Conditions
Keywords
Late stent malapposition, stent thrombosis, IVUS, non-polimeric stent
Brief summary
Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months follow-up. The investigators sought to compare the two stent types with the same drug to verify the polimer role. The polimer itself seems to provoke inflammation and hypersensibility if the arterial wall and it seems to be the base of a process of positive remodeling found at drug eluting stent implantation site. This positive remodeling is the mechanism producing late stent malapposition which on its turn can determine stent thrombosis, as demonstrated by pathological studies. At the same time the investigators will study the incidence of clinical events like myocardial infarction, stent thrombosis, TLR and death along with the incidence of angiographic restenosis at 2 years follow up.
Interventions
PROCEDUREPercutaneous transluminal Coronary Angioplasty
Coronary artery stent implantation
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with coronary artery stenosis in one, two or three vessels, and with objective evidence of isquemia. * The stenosis must allow IVUS analisis, must be treatable with angioplasty with stent * Target Vessel diameter must be between 2.25- 4 mm with QCA. * Patients must sign informed consent * Patients and their physician must accept the angiographic follow-up
Exclusion criteria
* 18 years old patients * SCA within the last 72 hours, or patients with CK twice over the upper normal limit * Pregnancy * Target vessel diameter \< 2.25 or \> 4 mm by QCA * Previous brakitherapy or DES in the target lesion * Restenotic lesion * -Allergy to aspirin, clopidogrel or ticlopidin * Patients enrolled in other studies or trials * By-pass graft lesions * Real bifurcationa lesions * Severe Renal insufficiency (creatinin clearance \< 30 ml/min). * Severe Liver failure(GOT y GPT \> 3 times the upper normal limit) * Life expectancy \< 1 year because of other pathologies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra coronary ultrasound analysis to verify stent malapposition at follow-up | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical events (myocardial infarction, TLR,at 1, 9, 12, 24 months follow-up:; Incidence of restenosis with QCA at 9 months follow-up Intimal hiperplasia measured by IVUS at 9 months follow-up; Stent Thrombosis. | 9 months and 2 years |
Countries
Spain
Contacts
Primary ContactManel Sabate, MD, PhD
Backup ContactClarissa Cola, MD
Outcome results
None listed