Stable AnginaDEMONSTRATENCT01543373
Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS
A study testing Amphilimus Eluting Stent and Bare Metal Stent in people with Stable Angina and Unstable Angina, run by CID - Carbostent & Implantable Devices at 6 sites in 2 countries.
Trial summary
The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina, NSTEMI
- What is being tested?
- Amphilimus Eluting Stent and Bare Metal Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2012to Apr 2014
- 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 or unstable angina and/or presence of a positive functional test for ischemia;
- Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
- Left ventricular ejection fraction > 30%;
- Patients presenting with at least two vessels disease requiring a staged procedure within 3 months, according to the operator judgement;
- Target de-novo lesion;
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- Target lesion located in a target vessel with a diameter ranging from 2.5 to 3.75 mm;
- Target lesion diameter stenosis > 50% and < 100% by visual estimate, with a TIMI flow of >=1;
- Discrete lesion with a length ranging from 13 to 25 mm;
- The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (Cre8 or Vision/Multilink 8), according to the randomization arm;
- 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;
- Patient presenting with acute myocardial infarction with ST elevation;
- Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
- Cerebrovascular accident within the past 6 months;
- Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
- Thrombocytopenia (platelet count less than 100,000/mm³);
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- Known bleeding or hypercoagulable disorder;
- Currently under immunosuppressant therapy;
- 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;
- Heavily calcified vessel and/or lesion which cannot be successfully predilated or imaged by OCT
- Target lesion is located or supplied by an arterial or venous bypass graft;
- Lesion located very distally, difficult to be imaged by OCT;
- Lesion located in angulated (>70°), sharp take-off vessel;
- Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;
- Target lesion located in the left main stem;
- Ostial lesion location;
- Target lesion has TIMI 0 flow;
- Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Italy5 sites
ULSS n°3 - Ospedale Civile
Bassano del Grappa, VI, 36061
Azienda Ospedaliero - Universitaria S.Anna
Ferrara, FE, 44121
Policlinico Universitario "Agostino Gemelli"
Roma, RM, 00168
Azienda Ospedaliera S. Giovanni - Addolorata
Roma, RM, 00184
Presidio Ospedaliero Umberto I - Azienda Ospedaliera "Ordine Mauriziano di Torino"
Torino, TO, 10128
About this study
Official title: Randomized Comparison Between a DES and a BMS to Assess Neointimal Coverage by OCT Evaluation
The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.
- Conditions
- Stable Angina, Unstable Angina, NSTEMI
- Being tested
- Amphilimus Eluting Stent, Bare Metal Stent
- Keywords
- Coronary artery disease, Optical Coherence Tomography, Tissue coverage, DES
- Medical subject headings
- Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphilimus Eluting StentDevice
Sirolimus formulated coronary eluting stent
Bare Metal StentDevice
Bare metal coronary stent
| Study group | Role | What they receive |
|---|---|---|
| CRE8 arm | Experimental | Not described Receives: Device: Amphilimus Eluting Stent |
| Vision/Multilik8 arm | Active comparator | Not described Receives: Device: Bare Metal Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT
1 month for the BMS arm; 3 months for the DES arm
Measured: within 3 months from index procedure
Secondary outcomes (6)
Percentage of malapposed stent struts
Measured: Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Percentage of malapposed and uncovered stent struts
Measured: 1 month (BMS arm) / 3 months (DES arm)
Neointimal growth and neointimal thickness
Measured: 1 month (BMS arm) / 3 months (DES arm)
Angiographic in-stent and in-segment endpoints
reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss
Measured: immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Clinical composite endpoints
- Cardiac death/Target vessel MI/Clinically indicated TLR
- All death/All MI/All TVR (including TLR)
Measured: At 1, 3 and 12 months
Stent Thrombosis
Measured: during index procedure, immediately after index procedure, 1 month, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionApr 2014
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- CID - Carbostent & Implantable Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Prati, MD, Principal investigator, Ospedale S. Giovanni - Addolorata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543373
- Sponsor's protocol ID
- C21101
- Acronym
- DEMONSTRATE
- Status last verified
- Apr 2018
- First submitted
- 20 Feb 2012
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between a DES and a BMS to Assess Neointimal Coverage by OCT Evaluation
- ClinicalTrials.gov ID
- NCT01543373
- Acronym / sponsor ID
- DEMONSTRATE / C21101
- Conditions
- Stable Angina, Unstable Angina, NSTEMI
- Keywords
- Coronary artery disease, Optical Coherence Tomography, Tissue coverage, DES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- CID - Carbostent & Implantable DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2012 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 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 purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRE8 arm | Experimental | Device: Amphilimus Eluting Stent |
| Vision/Multilik8 arm | Active comparator | Device: Bare Metal Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 18 years;
- Patients with symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
- Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
- Left ventricular ejection fraction > 30%;
- Patients presenting with at least two vessels disease requiring a staged procedure within 3 months, according to the operator judgement;
Key exclusion criteria (20 listed)
- Female with childbearing potential or lactating;
- Patient presenting with acute myocardial infarction with ST elevation;
- Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
- Cerebrovascular accident within the past 6 months;
- Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
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 StentSirolimus formulated coronary eluting stent | Device | CRE8 arm |
| Bare Metal StentBare metal coronary stent | Device | Vision/Multilik8 arm |
Primary outcome
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT
Time frame: within 3 months from index procedure
1 month for the BMS arm; 3 months for the DES arm
6 secondary outcomes
Percentage of malapposed stent struts
Time frame: Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Percentage of malapposed and uncovered stent struts
Time frame: 1 month (BMS arm) / 3 months (DES arm)
Neointimal growth and neointimal thickness
Time frame: 1 month (BMS arm) / 3 months (DES arm)
Angiographic in-stent and in-segment endpoints
Time frame: immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Clinical composite endpoints
Time frame: At 1, 3 and 12 months
Stent Thrombosis
Time frame: during index procedure, immediately after index procedure, 1 month, 3 months, 12 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 30 Apr 2018.
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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.
Francesco Prati, MD principal investigator
Ospedale S. Giovanni - Addolorata
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amphilimus Eluting Stent and Bare Metal Stent in people with Stable Angina and Unstable Angina, run by CID - Carbostent & Implantable Devices at 6 sites in 2 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 11 inclusion and 20 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 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Netherlands. 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?
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT (time frame: within 3 months from index procedure). 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 30 Apr 2018.