Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS

Not Applicable

Completed

• Conditions: Stable Angina; NSTEMI; Unstable Angina
• Interventions: Device: Bare Metal Stent; Device: Amphilimus Eluting Stent

• Registration Number: NCT01543373
• Lead Sponsor: CID - Carbostent & Implantable Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-03-05
• Primary Completion: 2013-08
• Study Completion: 2014-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vision/Multilik8 arm	Bare Metal Stent	-
CRE8 arm	Amphilimus Eluting Stent	-

Primary Outcome Measures

Name	Time	Method
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT	within 3 months from index procedure	1 month for the BMS arm; 3 months for the DES arm

Secondary Outcome Measures

Name	Time	Method
Stent Thrombosis	during index procedure, immediately after index procedure, 1 month, 3 months, 12 months
Percentage of malapposed stent struts	Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Neointimal growth and neointimal thickness	1 month (BMS arm) / 3 months (DES arm)
Clinical composite endpoints	At 1, 3 and 12 months	* Cardiac death/Target vessel MI/Clinically indicated TLR; * All death/All MI/All TVR (including TLR)
Percentage of malapposed and uncovered stent struts	1 month (BMS arm) / 3 months (DES arm)
Angiographic in-stent and in-segment endpoints	immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm)	reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss

Trial Locations

Locations (6)

Azienda Ospedaliero - Universitaria S.Anna; 🇮🇹 Ferrara, FE, Italy

Policlinico Universitario "Agostino Gemelli"; 🇮🇹 Roma, RM, Italy

Azienda Ospedaliera S. Giovanni - Addolorata; 🇮🇹 Roma, RM, Italy

Presidio Ospedaliero Umberto I - Azienda Ospedaliera "Ordine Mauriziano di Torino"; 🇮🇹 Torino, TO, Italy

ULSS n°3 - Ospedale Civile; 🇮🇹 Bassano del Grappa, VI, Italy

University Medical Centre Utrecht; 🇳🇱 Utrecht, Netherlands