Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS (NCT01543373) | Clinical Trial Compass
CompletedNot Applicable
Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS
Italy38 participantsStarted 2012-01
Plain-language summary
The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years;
* Patients with symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
* Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
* Left ventricular ejection fraction \> 30%;
* Patients presenting with at least two vessels disease requiring a staged procedure within 3 months, according to the operator judgement;
* Target de-novo lesion;
* Target lesion located in a target vessel with a diameter ranging from 2.5 to 3.75 mm;
* Target lesion diameter stenosis \> 50% and \< 100% by visual estimate, with a TIMI flow of \>=1;
* Discrete lesion with a length ranging from 13 to 25 mm;
* The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (Cre8 or Vision/Multilink 8), according to the randomization arm;
* Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.
Exclusion Criteria:
* Female with childbearing potential or lactating;
* Patient presenting with acute myocardial infarction with ST elevation;
* Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
* Cerebrovascular accident within the past 6 months;
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/d…
What they're measuring
1
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT