Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population (PARTICIPATE)
This study is currently recruiting participants.
Verified March 2012 by CID - Carbostent & Implantable Devices
Sponsor:
CID - Carbostent & Implantable Devices
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 | |
| Istituto Clinico Città Studi | Not yet recruiting |
| Milano, MI, Italy, 20131 | |
| Principal Investigator: Michele Bianchi, MD | |
| Fondazione San Raffaele del Monte Tabor | Recruiting |
| Milano, MI, Italy, 20132 | |
| Principal Investigator: Antonio Colombo, MD | |
| Centro Cardiologico Monzino | Recruiting |
| Milano, MI, Italy, 20138 | |
| Principal Investigator: Antonio Bartorelli, MD FESC FACC | |
| 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 | |
| Clinica Mediterranea SpA | Not yet recruiting |
| Napoli, Italy, 80122 | |
| Principal Investigator: Carlo Briguori, MD, PhD | |
| Azienda Ospedaliera Universitaria "Federico II" | Not yet recruiting |
| Napoli, Italy, 80131 | |
| Principal Investigator: Giovanni Esposito, 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 Pectoris Angina, Unstable Infarction Myocardial Infarction Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 19, 2013