Clinical trial NCT01556126: Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population
Official title: Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina
Unstable Angina
Acute Myocardial Infarction
Keywords: Coronary artery disease
Drug Eluting Stent
All comers patients
Lead sponsor: CID - Carbostent & Implantable Devices
Sponsor class: INDUSTRY
First posted: 2012-03-16
Enrollment: 1191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR
timeFrame: 6 months
Secondary outcomes:
measure: Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization
timeFrame: At 30 days, 1 year and yearly up to 5 years
measure: Stent thrombosis
timeFrame: within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years
measure: Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup).
timeFrame: At 6 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Arezzo
country: Italy
facility: Azienda USL 8 Arezzo - Ospedale San Donato
state: AR
city: Savigliano
country: Italy
facility: A.S.L. CN1 - Ospedale SS Annunziata di Savigliano
state: CN
city: Milano
country: Italy
facility: Istituto Clinico Città Studi
state: MI
city: Milano
country: Italy
facility: Fondazione San Raffaele del Monte Tabor
state: MI
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
state: MI
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas IRCCS
state: MI
city: Palermo
country: Italy
facility: Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli"
state: PA
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: PD
city: Pesaro
country: Italy
facility: Azienda Ospedaliera S. Salvatore
state: PU
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I
state: RM
city: Savona
country: Italy
facility: Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo
state: SV
city: Torino
country: Italy
facility: ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco
state: TO
city: Napoli
country: Italy
facility: Clinica Mediterranea SpA
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Tilburg
country: Netherlands
facility: TweeSteden Ziekenhuis
city: Oslo
country: Norway
facility: Oslo University Hospital - Rikshospitalet
city: Lublin
country: Poland
facility: Klinika Kardiologii SPSK4 w Lublinie
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego
Study officials:
affiliation: Fondazione San Raffaele del Monte Tabor
name: Antonio Colombo, MD
role: PRINCIPAL_INVESTIGATOR
References: