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

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ClinicalTrials.gov Identifier: NCT01556126
Recruitment Status : Active, not recruiting
First Posted : March 16, 2012
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stable Angina Unstable Angina Acute Myocardial Infarction Device: Amphilimus Eluting Stent (CRE8) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
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 : February 2012
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : December 2018

Intervention Details:
    Device: Amphilimus Eluting Stent (CRE8)
    Sirolimus formulated coronary eluting stent
    Other Name: CRE8


Primary Outcome Measures :
  1. Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR [ Time Frame: 6 months ]

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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556126


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

Responsible Party: CID - Carbostent & Implantable Devices
ClinicalTrials.gov Identifier: NCT01556126     History of Changes
Other Study ID Numbers: C21102
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Keywords provided by CID - Carbostent & Implantable Devices:
Coronary artery disease
Drug Eluting Stent
All comers patients

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Angina Pectoris
Angina, Stable
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms