Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population

Not Applicable

Completed

• Conditions: Unstable Angina; Stable Angina; Acute Myocardial Infarction
• Interventions: Device: Amphilimus Eluting Stent (CRE8)

• Registration Number: NCT01556126
• Lead Sponsor: CID - Carbostent & Implantable Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Primary Completion: 2014-07
• Study Completion: 2018-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1191

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amphilimus eluting stent (Cre8)	Amphilimus Eluting Stent (CRE8)	Sirolimus formulated coronary eluting stent

Primary Outcome Measures

Name	Time	Method
Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR	6 months

Secondary Outcome Measures

Name	Time	Method
Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup).	At 6 months	reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss
Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization	At 30 days, 1 year and yearly up to 5 years
Stent thrombosis	within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years

Trial Locations

Locations (23)

TweeSteden Ziekenhuis; 🇳🇱 Tilburg, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

Istituto Clinico Città Studi; 🇮🇹 Milano, MI, Italy

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Oslo University Hospital - Rikshospitalet; 🇳🇴 Oslo, Norway

Szpital Kliniczny Przemienienia Panskiego; 🇵🇱 Poznan, Poland

Centro Cardiologico Monzino; 🇮🇹 Milano, MI, Italy

Azienda USL 8 Arezzo - Ospedale San Donato; 🇮🇹 Arezzo, AR, Italy

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Klinika Kardiologii SPSK4 w Lublinie; 🇵🇱 Lublin, Poland

Azienda Policlinico Umberto I; 🇮🇹 Roma, RM, Italy

A.S.L. CN1 - Ospedale SS Annunziata di Savigliano; 🇮🇹 Savigliano, CN, Italy

Fondazione San Raffaele del Monte Tabor; 🇮🇹 Milano, MI, Italy

Istituto Clinico Humanitas IRCCS; 🇮🇹 Rozzano, MI, Italy

Azienda Ospedaliera S. Salvatore; 🇮🇹 Pesaro, PU, Italy

Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo; 🇮🇹 Savona, SV, Italy

ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco; 🇮🇹 Torino, TO, Italy

Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli"; 🇮🇹 Palermo, PA, Italy

Clinica Mediterranea SpA; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Universitaria "Federico II"; 🇮🇹 Napoli, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, PD, Italy

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria