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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by CID - Carbostent & Implantable Devices
Sponsor:
Information provided by (Responsible Party):
CID - Carbostent & Implantable Devices
ClinicalTrials.gov Identifier:
NCT01556126
First received: March 14, 2012
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Stable Angina
Unstable Angina
Acute Myocardial Infarction
Device: Amphilimus Eluting Stent (CRE8)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients

Resource links provided by NLM:


Further study details as provided by CID - Carbostent & Implantable Devices:

Primary Outcome Measures:
  • Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup). [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss


Estimated Enrollment: 1000
Study Start Date: February 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Amphilimus Eluting Stent (CRE8)
    Sirolimus formulated coronary eluting stent
    Other Name: CRE8
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556126

Contacts
Contact: Cristina Isaia 0030-0161-1826291 cristina.isaia@cidvascular.com

Locations
Austria
Medizinische Universität Innsbruck Not yet recruiting
Innsbruck, Austria, 6020
Principal Investigator: Otmar Pachinger, MD FESC FAHA         
Belgium
Ziekenhuis Oost Limburg Not yet recruiting
Genk, Belgium, 3600
Principal Investigator: Mathias Vrolix, MD         
Italy
Azienda USL 8 Arezzo - Ospedale San Donato Not yet recruiting
Arezzo, AR, Italy, 52100
Principal Investigator: Leonardo Bolognese, MD, FESC         
A.S.L. CN1 - Ospedale SS Annunziata di Savigliano Not yet recruiting
Savigliano, CN, Italy, 12038
Principal Investigator: Baldassarre Doronzo, MD         
Centro Cardiologico Monzino Recruiting
Milano, MI, Italy, 20138
Principal Investigator: Antonio Bartorelli, MD FESC FACC         
Fondazione San Raffaele del Monte Tabor Recruiting
Milano, MI, Italy, 20132
Principal Investigator: Antonio Colombo, MD         
Istituto Clinico Città Studi Not yet recruiting
Milano, MI, Italy, 20131
Principal Investigator: Michele Bianchi, MD         
Istituto Clinico Humanitas IRCCS Recruiting
Rozzano, MI, Italy, 20089
Principal Investigator: Patrizia Presbitero, MD         
Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli" Not yet recruiting
Palermo, PA, Italy, 90127
Principal Investigator: Amerigo Stabile, MD         
Azienda Ospedaliera di Padova Not yet recruiting
Padova, PD, Italy, 35128
Principal Investigator: Giambattista Isabella, MD         
Azienda Ospedaliera S. Salvatore Not yet recruiting
Pesaro, PU, Italy, 61100
Principal Investigator: Rossella Fattori, MD         
Azienda Policlinico Umberto I Recruiting
Roma, RM, Italy, 00161
Principal Investigator: Gennaro Sardella, MD FACC FESC         
Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo Not yet recruiting
Savona, SV, Italy, 17100
Principal Investigator: Paolo Bellotti, MD         
ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco Not yet recruiting
Torino, TO, Italy, 10154
Principal Investigator: Roberto Garbo, MD         
Azienda Ospedaliera Universitaria "Federico II" Not yet recruiting
Napoli, Italy, 80131
Principal Investigator: Giovanni Esposito, MD, PhD         
Clinica Mediterranea SpA Not yet recruiting
Napoli, Italy, 80122
Principal Investigator: Carlo Briguori, MD, PhD         
Netherlands
Onze Lieve Vrouwe Gasthuis Not yet recruiting
Amsterdam, Netherlands, 1091 AC
Principal Investigator: Ton Slagboom, MD         
Catharina Ziekenhuis Not yet recruiting
Eindhoven, Netherlands, 5623 EJ
Principal Investigator: Jacques Koolen, MD, PhD         
St. Antonius Ziekenhuis Not yet recruiting
Nieuwegein, Netherlands, 3435CM
Principal Investigator: Marteen Suttorp, MD, PhD, FESC, FACC         
TweeSteden Ziekenhuis Not yet recruiting
Tilburg, Netherlands, 5042 AD
Principal Investigator: Willen Dewilde, MD         
Norway
Oslo University Hospital - Rikshospitalet Not yet recruiting
Oslo, Norway, 0027
Principal Investigator: Knut Endresen, MD, PhD         
Poland
Klinika Kardiologii SPSK4 w Lublinie Not yet recruiting
Lublin, Poland, 20-954
Principal Investigator: Jaroslaw Wójcik, MD, PhD         
Szpital Kliniczny Przemienienia Panskiego Not yet recruiting
Poznan, Poland, 61-848
Principal Investigator: Maciej Lesiak, MD, PhD         
Sponsors and Collaborators
CID - Carbostent & Implantable Devices
Investigators
Principal Investigator: Antonio Colombo, MD Fondazione San Raffaele del Monte Tabor
  More Information

No publications provided

Responsible Party: CID - Carbostent & Implantable Devices
ClinicalTrials.gov Identifier: NCT01556126     History of Changes
Other Study ID Numbers: C21102
Study First Received: March 14, 2012
Last Updated: March 15, 2012
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014