minimizes neointimal hyperplasia, as compared to a technique of BMS implantation alone, 2. influences strut coverage and strut malapposition. Aims of endothelial progenitor cell ancillary study To evaluate achievable correlations of EPC levels with neoin timal hyperplasia, stent coverage and stent malapposition. Methods/Design Research design The INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions handled by drug eluting balloon and bare metal stent trial is really a single cen ter, open label, randomized trial enrolling thirty consecutive sufferers undergoing PCI with BMS implantation. Recruited individuals will probably be randomized one,1,1 to three arms, one. BMS implantation. 2. BMS implantation right after lesion pre dilation with DEB. 3. BMS implantation followed by post dilation with DEB.
Clinical comply with up might be performed at one, six and twelve months. Enrolled patients will undergo a 6 month fol lower up coronary angiography with OCT evaluation in the stented segment utilizing the C7 XRTM Coronary Im aging Technique. OCT evaluation are going to be carried out off line by skilled OCT analysts blinded to your treatment method assignment. The study protocol was conceived selleck inhibitor in March 2009, con formed for the Declaration of Helsinki, and was authorized through the Ethical Committee of our center. We ready a written informed consent which patients is going to be asked to sign for being enrolled in the protocol. The total review flow chart is represented in Figure 1. Study endpoints The main endpoint is six month in stent neointimal hyperplasia spot assessed by OCT. Secondary endpoints would be the six month percentage of uncovered struts as well as the 6 month percentage of struts with incomplete stent apposition.
Eligibility, inclusion selleckchem and exclusion criteria Eligible individuals must be at the very least 18 years previous, each genders are eligible but girls with kid bearing poten tial are usually not accepted. Because the study will recruit a smaller variety of individuals, we picked a homogeneous population of secure non diabetic individuals undergoing elective PCI with BMS and by now on statin at target dose for low density lipopro tein cholesterol degree a hundred mg/dL. Given that diabetes melli tus is known to considerably increase neointimal hyperplasia right after BMS implantation and acute coronary syndromes may possibly influence acute stent apposition towards the vessel wall, we made the decision to exclude such clinical situations so that you can lower the likelihood of any im stability of confounding things.
We picked de novo, non complex lesions with length ten mm and 25 mm, located in straight segments of vessels whose size demands a single stent with diameter of 3. 0 to three. 5 mm. Clinical and angiographic inclusion cri teria are summarized in Table 1. Clinical exclusion criteria Clinical exclusion criteria are, age 18 years or impossibility to offer informed consent, females with child bearing possible, diabetes mellitus, existence expectancy less than 6 months or any problem impeding clinical follow up, major platelet count alteration, gastrointestinal bleeding requiring surgical treatment or blood transfusions inside of the former 4 weeks, participation to a different examine with any investigational gadget or drug that is nevertheless while in the lively phase, infective, neoplastic or autoimmune disorders, historical past of clotting pathology, regarded hypersensitivity to aspirin, heparin, cobalt chromium, paclitaxel or contrast dye, renal failure with creatinine value two.