Clinical trial NCT01543373: Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS
Official title: Randomized Comparison Between a DES and a BMS to Assess Neointimal Coverage by OCT Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina
Unstable Angina
NSTEMI
Keywords: Coronary artery disease
Optical Coherence Tomography
Tissue coverage
DES
Lead sponsor: CID - Carbostent & Implantable Devices
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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/dl);
* Thrombocytopenia (platelet count less than 100,000/mm³);
* Known bleeding or hypercoagulable disorder;
* Currently under immunosuppressant therapy;
* Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
* Patient underwent target vessel revascularization with a DES;
* Heavily calcified vessel and/or lesion which cannot be successfully predilated or imaged by OCT
* Target lesion is located or supplied by an arterial or venous bypass graft;
* Lesion located very distally, difficult to be imaged by OCT;
* Lesion located in angulated (\>70°), sharp take-off vessel;
* Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;
* Target lesion located in the left main stem;
* Ostial lesion location;
* Target lesion has TIMI 0 flow;
* Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.

Primary outcomes:
measure: Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT
timeFrame: within 3 months from index procedure
Secondary outcomes:
measure: Percentage of malapposed stent struts
timeFrame: Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm)
measure: Percentage of malapposed and uncovered stent struts
timeFrame: 1 month (BMS arm) / 3 months (DES arm)
measure: Neointimal growth and neointimal thickness
timeFrame: 1 month (BMS arm) / 3 months (DES arm)
measure: Angiographic in-stent and in-segment endpoints
timeFrame: immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm)
measure: Clinical composite endpoints
timeFrame: At 1, 3 and 12 months
measure: Stent Thrombosis
timeFrame: during index procedure, immediately after index procedure, 1 month, 3 months, 12 months
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero - Universitaria S.Anna
state: FE
city: Roma
country: Italy
facility: Policlinico Universitario "Agostino Gemelli"
state: RM
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Giovanni - Addolorata
state: RM
city: Torino
country: Italy
facility: Presidio Ospedaliero Umberto I - Azienda Ospedaliera "Ordine Mauriziano di Torino"
state: TO
city: Bassano del Grappa
country: Italy
facility: ULSS n°3 - Ospedale Civile
state: VI
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
Study officials:
affiliation: Ospedale S. Giovanni - Addolorata
name: Francesco Prati, MD
role: PRINCIPAL_INVESTIGATOR
References: