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

Primary Purpose

Stable Angina, Unstable Angina, Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Amphilimus Eluting Stent (CRE8)
Sponsored by
CID - Carbostent & Implantable Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring Coronary artery disease, Drug Eluting Stent, All comers patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Medizinische Universität Innsbruck
  • Ziekenhuis Oost Limburg
  • Azienda USL 8 Arezzo - Ospedale San Donato
  • A.S.L. CN1 - Ospedale SS Annunziata di Savigliano
  • Istituto Clinico Città Studi
  • Fondazione San Raffaele del Monte Tabor
  • Centro Cardiologico Monzino
  • Istituto Clinico Humanitas IRCCS
  • Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli"
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera S. Salvatore
  • Azienda Policlinico Umberto I
  • Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo
  • ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco
  • Clinica Mediterranea SpA
  • Azienda Ospedaliera Universitaria "Federico II"
  • Onze Lieve Vrouwe Gasthuis
  • Catharina Ziekenhuis
  • St. Antonius Ziekenhuis
  • TweeSteden Ziekenhuis
  • Oslo University Hospital - Rikshospitalet
  • Klinika Kardiologii SPSK4 w Lublinie
  • Szpital Kliniczny Przemienienia Panskiego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amphilimus eluting stent (Cre8)

Arm Description

Sirolimus formulated coronary eluting stent

Outcomes

Primary Outcome Measures

Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR

Secondary Outcome Measures

Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization
Stent thrombosis
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

Full Information

First Posted
March 14, 2012
Last Updated
July 14, 2021
Sponsor
CID - Carbostent & Implantable Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01556126
Brief Title
Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population
Acronym
PARTICIPATE
Official Title
Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CID - Carbostent & Implantable Devices

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Unstable Angina, Acute Myocardial Infarction
Keywords
Coronary artery disease, Drug Eluting Stent, All comers patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amphilimus eluting stent (Cre8)
Arm Type
Experimental
Arm Description
Sirolimus formulated coronary eluting stent
Intervention Type
Device
Intervention Name(s)
Amphilimus Eluting Stent (CRE8)
Other Intervention Name(s)
CRE8
Intervention Description
Sirolimus formulated coronary eluting stent
Primary Outcome Measure Information:
Title
Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Title
Stent thrombosis
Time Frame
within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years
Title
Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup).
Description
reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Colombo, MD
Organizational Affiliation
Fondazione San Raffaele del Monte Tabor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Ziekenhuis Oost Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Azienda USL 8 Arezzo - Ospedale San Donato
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
Facility Name
A.S.L. CN1 - Ospedale SS Annunziata di Savigliano
City
Savigliano
State/Province
CN
ZIP/Postal Code
12038
Country
Italy
Facility Name
Istituto Clinico Città Studi
City
Milano
State/Province
MI
ZIP/Postal Code
20131
Country
Italy
Facility Name
Fondazione San Raffaele del Monte Tabor
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Name
Centro Cardiologico Monzino
City
Milano
State/Province
MI
ZIP/Postal Code
20138
Country
Italy
Facility Name
Istituto Clinico Humanitas IRCCS
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli"
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera S. Salvatore
City
Pesaro
State/Province
PU
ZIP/Postal Code
61100
Country
Italy
Facility Name
Azienda Policlinico Umberto I
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo
City
Savona
State/Province
SV
ZIP/Postal Code
17100
Country
Italy
Facility Name
ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco
City
Torino
State/Province
TO
ZIP/Postal Code
10154
Country
Italy
Facility Name
Clinica Mediterranea SpA
City
Napoli
ZIP/Postal Code
80122
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "Federico II"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435CM
Country
Netherlands
Facility Name
TweeSteden Ziekenhuis
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Oslo University Hospital - Rikshospitalet
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Klinika Kardiologii SPSK4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego
City
Poznan
ZIP/Postal Code
61-848
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population

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