Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population

Acute Myocardial Infarction Clinical Trial

— PARTICIPATE  

Official title:

Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556126
• Other study ID #: C21102
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: December 2018

Study information

• Verified date: July 2021
• Source: CID - Carbostent & Implantable Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1191
• Est. completion date: December 2018
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Stable Angina
• Unstable Angina

Intervention

Device:
• Amphilimus Eluting Stent (CRE8)
Sirolimus formulated coronary eluting stent

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck
Belgium	Ziekenhuis Oost Limburg	Genk
Italy	Azienda USL 8 Arezzo - Ospedale San Donato	Arezzo	AR
Italy	Centro Cardiologico Monzino	Milano	MI
Italy	Fondazione San Raffaele del Monte Tabor	Milano	MI
Italy	Istituto Clinico Città Studi	Milano	MI
Italy	Azienda Ospedaliera Universitaria "Federico II"	Napoli
Italy	Clinica Mediterranea SpA	Napoli
Italy	Azienda Ospedaliera di Padova	Padova	PD
Italy	Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli"	Palermo	PA
Italy	Azienda Ospedaliera S. Salvatore	Pesaro	PU
Italy	Azienda Policlinico Umberto I	Roma	RM
Italy	Istituto Clinico Humanitas IRCCS	Rozzano	MI
Italy	A.S.L. CN1 - Ospedale SS Annunziata di Savigliano	Savigliano	CN
Italy	Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo	Savona	SV
Italy	ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco	Torino	TO
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	TweeSteden Ziekenhuis	Tilburg
Norway	Oslo University Hospital - Rikshospitalet	Oslo
Poland	Klinika Kardiologii SPSK4 w Lublinie	Lublin
Poland	Szpital Kliniczny Przemienienia Panskiego	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
CID - Carbostent & Implantable Devices

Countries where clinical trial is conducted

Austria,  Belgium,  Italy,  Netherlands,  Norway,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR		6 months
Secondary	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
Secondary	Stent thrombosis		within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years
Secondary	Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup).	reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss	At 6 months