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

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

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.

Study Overview

• Status: Completed
• Conditions: Stable Angina; Acute Myocardial Infarction; Unstable Angina
• Intervention / Treatment: Device: Amphilimus Eluting Stent (CRE8)

• Study Type: Interventional
• Enrollment (Actual): 1191
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss	At 6 months

Collaborators and Investigators

• Sponsor: CID - Carbostent & Implantable Devices
• Investigators: Principal Investigator: Antonio Colombo, MD, Fondazione San Raffaele del Monte Tabor

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 15, 2012
• First Posted (Estimate): March 16, 2012

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Coronary artery disease; Drug Eluting Stent; All comers patients
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: C21102