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

NCT ID: NCT01543373

Last Updated: 2018-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-04-30

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.

Conditions

Stable Angina; Unstable Angina; NSTEMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRE8 arm

Group Type: EXPERIMENTAL

Amphilimus Eluting Stent

Intervention Type: DEVICE

Sirolimus formulated coronary eluting stent

Vision/Multilik8 arm

Group Type: ACTIVE_COMPARATOR

Bare Metal Stent

Intervention Type: DEVICE

Bare metal coronary stent

Interventions

Amphilimus Eluting Stent

Sirolimus formulated coronary eluting stent

Intervention Type: DEVICE

Bare Metal Stent

Bare metal coronary stent

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CID - Carbostent & Implantable Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Prati, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale S. Giovanni - Addolorata

Locations

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

Countries

Italy; Netherlands

Other Identifiers

C21101

Identifier Type: -

Identifier Source: org_study_id