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

CID Carbostent & Implantable Devices

Status

Completed

Conditions

Unstable Angina

Stable Angina

NSTEMI

Treatments

Device: Amphilimus Eluting Stent

Device: Bare Metal Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT01543373

C21101

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.