Stable AnginaPARTICIPATENCT01556126
Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population
A study testing Amphilimus Eluting Stent (CRE8) in people with Stable Angina and Unstable Angina, run by CID - Carbostent & Implantable Devices at 23 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina, Acute Myocardial Infarction
- What is being tested?
- Amphilimus Eluting Stent (CRE8)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,191 participants
- Where
- 23 sitesin 6 countries
- Study dates
- Feb 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
Italy14 sites
Azienda USL 8 Arezzo - Ospedale San Donato
Arezzo, AR, 52100
Istituto Clinico Città Studi
Milan, MI, 20131
Fondazione San Raffaele del Monte Tabor
Milan, MI, 20132
Centro Cardiologico Monzino
Milan, MI, 20138
Clinica Mediterranea SpA
Naples, 80122
Azienda Ospedaliera Universitaria "Federico II"
Naples, 80131
Azienda Ospedaliera di Padova
Padova, PD, 35128
Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli"
Palermo, PA, 90127
Azienda Ospedaliera S. Salvatore
Pesaro, PU, 61100
Azienda Policlinico Umberto I
Roma, RM, 00161
Istituto Clinico Humanitas IRCCS
Rozzano, MI, 20089
A.S.L. CN1 - Ospedale SS Annunziata di Savigliano
Savigliano, CN, 12038
Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo
Savona, SV, 17100
ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco
Torino, TO, 10154
Netherlands4 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC
Catharina Ziekenhuis
Eindhoven, 5623 EJ
St. Antonius Ziekenhuis
Nieuwegein, 3435CM
TweeSteden Ziekenhuis
Tilburg, 5042 AD
Poland2 sites
Klinika Kardiologii SPSK4 w Lublinie
Lublin, 20-954
Szpital Kliniczny Przemienienia Panskiego
Poznan, 61-848
About this study
Official title: 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.
- Conditions
- Stable Angina, Unstable Angina, Acute Myocardial Infarction
- Being tested
- Amphilimus Eluting Stent (CRE8)
- Keywords
- Coronary artery disease, Drug Eluting Stent, All comers patients
- Medical subject headings
- Angina, Stable, Angina, Unstable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphilimus Eluting Stent (CRE8)Device
Also called CRE8
Sirolimus formulated coronary eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Amphilimus eluting stent (Cre8) | Experimental | Sirolimus formulated coronary eluting stent Receives: Device: Amphilimus Eluting Stent (CRE8) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR
Measured: 6 months
Secondary outcomes (3)
Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization
Measured: At 30 days, 1 year and yearly up to 5 years
Stent thrombosis
Measured: 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
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2014
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,191 participants (actual)
Sponsor and investigators
- Lead sponsor
- CID - Carbostent & Implantable Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Colombo, MD, Principal investigator, Fondazione San Raffaele del Monte Tabor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556126
- Sponsor's protocol ID
- C21102
- Acronym
- PARTICIPATE
- Status last verified
- Jul 2021
- First submitted
- 14 Mar 2012
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients
- ClinicalTrials.gov ID
- NCT01556126
- Acronym / sponsor ID
- PARTICIPATE / C21102
- Conditions
- Stable Angina, Unstable Angina, Acute Myocardial Infarction
- Keywords
- Coronary artery disease, Drug Eluting Stent, All comers patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,191 participants (actual)
- Lead sponsor
- CID - Carbostent & Implantable DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2012 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amphilimus eluting stent (Cre8) | Experimental | Device: Amphilimus Eluting Stent (CRE8)Sirolimus formulated coronary eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphilimus Eluting Stent (CRE8)Also: CRE8Sirolimus formulated coronary eluting stent | Device | Amphilimus eluting stent (Cre8) |
Primary outcome
Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR
Time frame: 6 months
3 secondary outcomes
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
Stent thrombosis
Time frame: 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).
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
Related trials for Stable Angina
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Colombo, MD principal investigator
Fondazione San Raffaele del Monte Tabor
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amphilimus Eluting Stent (CRE8) in people with Stable Angina and Unstable Angina, run by CID - Carbostent & Implantable Devices at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Italy, Netherlands, Poland, Austria, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.