PARTICIPATE: Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population

Sponsor

CID - Carbostent & Implantable Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT01556126

Collaborator

(none)

1,191

Enrollment

Locations

Arm

Actual Duration (Months)

51.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Unstable Angina Acute Myocardial Infarction	Device: Amphilimus Eluting Stent (CRE8)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1191 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amphilimus eluting stent (Cre8) Sirolimus formulated coronary eluting stent	Device: Amphilimus Eluting Stent (CRE8) Sirolimus formulated coronary eluting stent Other Names: CRE8

Arm

Intervention/Treatment

Experimental: Amphilimus eluting stent (Cre8)

Sirolimus formulated coronary eluting stent

Device: Amphilimus Eluting Stent (CRE8)

Sirolimus formulated coronary eluting stent

Other Names:

CRE8

Outcome Measures

Primary Outcome Measures

Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR [6 months]

Secondary Outcome Measures

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]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Universität Innsbruck	Innsbruck		Austria	6020
2	Ziekenhuis Oost Limburg	Genk		Belgium	3600
3	Azienda USL 8 Arezzo - Ospedale San Donato	Arezzo	AR	Italy	52100
4	A.S.L. CN1 - Ospedale SS Annunziata di Savigliano	Savigliano	CN	Italy	12038
5	Istituto Clinico Città Studi	Milano	MI	Italy	20131
6	Fondazione San Raffaele del Monte Tabor	Milano	MI	Italy	20132
7	Centro Cardiologico Monzino	Milano	MI	Italy	20138
8	Istituto Clinico Humanitas IRCCS	Rozzano	MI	Italy	20089
9	Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli"	Palermo	PA	Italy	90127
10	Azienda Ospedaliera di Padova	Padova	PD	Italy	35128
11	Azienda Ospedaliera S. Salvatore	Pesaro	PU	Italy	61100
12	Azienda Policlinico Umberto I	Roma	RM	Italy	00161
13	Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo	Savona	SV	Italy	17100
14	ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco	Torino	TO	Italy	10154
15	Clinica Mediterranea SpA	Napoli		Italy	80122
16	Azienda Ospedaliera Universitaria "Federico II"	Napoli		Italy	80131
17	Onze Lieve Vrouwe Gasthuis	Amsterdam		Netherlands	1091 AC
18	Catharina Ziekenhuis	Eindhoven		Netherlands	5623 EJ
19	St. Antonius Ziekenhuis	Nieuwegein		Netherlands	3435CM
20	TweeSteden Ziekenhuis	Tilburg		Netherlands	5042 AD
21	Oslo University Hospital - Rikshospitalet	Oslo		Norway	0027
22	Klinika Kardiologii SPSK4 w Lublinie	Lublin		Poland	20-954
23	Szpital Kliniczny Przemienienia Panskiego	Poznan		Poland	61-848