Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population

NCT ID: NCT01556126

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2018-12-31

Brief Summary

The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting Stent, in patients comparable to the everyday's clinical practice population, with a specific focus on diabetics, that will be part of a pre-specified study subgroup.

Conditions

Stable Angina; Unstable Angina; Acute Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Amphilimus eluting stent (Cre8)

Sirolimus formulated coronary eluting stent

Group Type: EXPERIMENTAL

Amphilimus Eluting Stent (CRE8)

Intervention Type: DEVICE

Sirolimus formulated coronary eluting stent

Interventions

Amphilimus Eluting Stent (CRE8)

Sirolimus formulated coronary eluting stent

Intervention Type: DEVICE

Other Intervention Names

CRE8

Eligibility Criteria

Inclusion Criteria

• Age > 18 years;
• Patients with symptoms of stable angina or documented silent ischemia;
• Patient with coronary artery disease ranging between 0 and 22 according to the Syntax score;
• Patients with acute coronary syndrome, including unstable angina, NSTEMI and STEMI;
• Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
• Left ventricular ejection fraction > 30%;
• Target de-novo lesions with diameter stenosis > 50% (including total occlusion);
• Target lesion located in a target vessel with a diameter ranging from 2.5 to 4.0 mm;
• 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;
• Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
• Acute or chronic renal dysfunction (defined as creatinine greater than 2.5 mg/dl or on dialysis);
• Thrombocytopenia (platelet count less than 100,000/mm³) or hypercoagulable disorder;
• Known significant gastro-intestinal or urinary bleeding within the past 6 months;
• Patient refusing blood transfusion;
• Patient currently under immunosuppressant therapy;
• Patient with planned surgery within 6 months from the index procedure unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
• 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 within 3 months prior to the index procedure;
• Target lesion is located or supplied by an arterial or venous bypass graft.

• 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

Antonio Colombo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione San Raffaele del Monte Tabor

Locations

Medizinische Universität Innsbruck

Innsbruck, , Austria

Ziekenhuis Oost Limburg

Genk, , Belgium

Azienda USL 8 Arezzo - Ospedale San Donato

Arezzo, AR, Italy

A.S.L. CN1 - Ospedale SS Annunziata di Savigliano

Savigliano, CN, Italy

Istituto Clinico Città Studi

Milan, MI, Italy

Fondazione San Raffaele del Monte Tabor

Milan, MI, Italy

Centro Cardiologico Monzino

Milan, MI, Italy

Istituto Clinico Humanitas IRCCS

Rozzano, MI, Italy

Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli"

Palermo, PA, Italy

Azienda Ospedaliera di Padova

Padua, PD, Italy

Azienda Ospedaliera S. Salvatore

Pesaro, PU, Italy

Azienda Policlinico Umberto I

Roma, RM, Italy

Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo

Savona, SV, Italy

ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco

Torino, TO, Italy

Clinica Mediterranea SpA

Napoli, , Italy

Azienda Ospedaliera Universitaria "Federico II"

Napoli, , Italy

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

TweeSteden Ziekenhuis

Tilburg, , Netherlands

Oslo University Hospital - Rikshospitalet

Oslo, , Norway

Klinika Kardiologii SPSK4 w Lublinie

Lublin, , Poland

Szpital Kliniczny Przemienienia Panskiego

Poznan, , Poland

Countries

Austria; Belgium; Italy; Netherlands; Norway; Poland

Other Identifiers

C21102

Identifier Type: -

Identifier Source: org_study_id