Coronary Artery DiseaseIDEAL-LMNCT02303717
Xience Versus Synergy in Left Main PCI
A study testing Percutaneous coronary intervention and Dual antiplatelet therapy in people with Coronary Artery Disease, run by NHS National Waiting Times Centre Board.
Trial summary
A prospective, randomized, multicenter study in patients with an indication for coronary artery revascularisation who have been accepted for percutaneous coronary intervention (PCI) of the left main coronary artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention and Dual antiplatelet therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2020
- 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
- Patients with an indication for coronary artery revascularisation by ESC guidelines and accepted for PCI of the left main coronary artery will be included in the study.
- Main inclusion criteria:
- Patient has an indication for coronary artery revascularisation of the left main artery in accordance with the ESC guidelines
- Patient has been discussed with the cardiac surgeon prior to PCI procedure
- Patient is accepted for PCI
- Patient is at least 18 years of age.
- The patient understands and accepts the meaning and the aims of the study and is willing to provide written informed consent
- The patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
Who cannot join
- Not able to receive anti-platelet treatment due to contraindications
- Known allergy to acetylsalicylic acid, clopidogrel, prasugrel or ticagrelor
- Cardiogenic shock
- STEMI within the last 5 days
- Planned surgery within 12 months after stent introduction
- History of bleeding diathesis or active major bleedings
Show all 11Show fewer
- Major surgery within previous 15 days
- Current participation in another trial which has not yet reached its primary endpoint
- Life expectancy < 12 months
- Hypersensitivity or contraindication to everolimus or structurally-related compounds, cobalt, chromium, nickel, tungsten, acrylic, platinum and fluoropolymers
- Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Improved Drug Eluting Stent for Percutaneous Coronary Intervention of the Left Main Artery in a Real World All-comers Population
A prospective, randomized, multicenter study in patients with an indication for coronary artery revascularisation who have been accepted for percutaneous coronary intervention (PCI) of the left main coronary artery. Patients will undergo standard PCI of the left main coronary artery and will be randomized in a 1:1 fashion to the Synergy stent or to the XIENCE stent. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy arm whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100 patients will have control angiography with Optical Coherence Tomography (OCT) at t=3 months after treatment.
Read the detailed description
PCI of the left main coronary artery is a complex procedure with increased risk of both short and long-term major cardiac adverse events. With the use of coronary artery stents the outcome has significant improved and PCI of the left main is included in the European Society Cardiology guidelines [8]. However the results of first generation drug eluting stents still show significant room for improvement, as the risk of very late stent thrombosis has been shown to accrue up to 5 year follow-up. The newest generation of drug eluting stents have improved radial strength with thinner strut thickness, bioresorbable coatings for local drug delivery which are resorbed in 3 months and are applied only direct to the vessel wall. These stents have been evaluated in non-complex disease with good results. A comparison of the newest generation drug eluting stents in combination with a short duration of dual antiplatelet therapy versus current standard PCI techniques in complex PCI of left main coronary artery disease is therefore desirable.
The study stent (Synergy) is an evolution of currently used drug eluting stents and in initial trials demonstrated similar results for surrogate endpoints [4,5] On clinical endpoints no difference has been demonstrated. This results in a very small possibility of inferiority to current stents where re-intervention is the largest risk. For shortening DAPT several non-randomized studies have shown high safety with a very low risk (1%) of stent thrombosis [6]. Based on the improved properties of the study stent (biodegradable coating) the risk of early DAPT discontinuation should be minimal. For the relevant subgroup control coronary angiography with the additional use of OCT imaging can be considered a standard procedure with a very low risk of major complications (0.4%) [7] This study will investigate the short term angiographic and long term clinical outcome of after implantation of an improved drug eluting coronary artery stent (Everolimus-eluting Platinum Chromium Stent with Abluminal Bioabsorbable Polymer) with shorter post interventional dual antiplatelet therapy (DAPT) in comparison to a conventional drug eluting stent with a permanent Polymer followed by 12 months DAPT for treatment of unprotected left main coronary artery disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention, Dual antiplatelet therapy
- Keywords
- Left main, PCI, DES
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionDevice
Also called PCI
Percutaneous coronary stent implantation
Dual antiplatelet therapyDrug
Also called DAPT
Dual antiplatelet therapy with aspirin and either clopidogrel, prasugrel or ticagrelor will be recommended for 12 months duration in the Xience stent arm but only 4 months duration in the Synergy stent arm.
| Study group | Role | What they receive |
|---|---|---|
| Xience | Active comparator | Percutaneous coronary intervention utilising a cobalt chromium everolimus eluting stent with durable polymer (Xience) plus oral dual antiplatelet therapy (DAPT) for 12 months. DAPT will be aspirin 75-100mg daily plus either clopidogrel 75mg daily or prasugrel 5-10mg daily or ticagrelor 90mg twice daily. Receives: Device: Percutaneous coronary intervention; Drug: Dual antiplatelet therapy |
| Synergy | Experimental | Percutaneous coronary intervention utilising a platinum chromium everolimus eluting stent with bioresorbable polymer (Synergy) plus oral dual antiplatelet therapy (DAPT) for 4 months. DAPT will be aspirin 75-100mg daily plus either clopidogrel 75mg daily or prasugrel 5-10mg daily or ticagrelor 90mg twice daily. Receives: Device: Percutaneous coronary intervention; Drug: Dual antiplatelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
The primary endpoint is the rate of MACE defined as death from any cause or MI or ischemia-driven target vessel revascularization (TVR) at 2 years after the procedure.
Measured: 2 years
Secondary outcomes (7)
All cause mortality
Component of the primary endpoint (MACE)
Measured: 2 years
MI
Myocardial infarction as defined in protocol. Component of combined primary end-point (MACE)
Measured: 2 years
Ischaemia driven target vessel revascularisation
Component of combined primary end-point (MACE)
Measured: 2 years
Procedural success
Attainment of <30% residual stenosis of the target lesion and no in-hospital device-oriented composite endpoints (DOCE) defined as cardiac death, MI not clearly attributable to a non-treated vessel, and clinically-indicated target lesion revascularization.).
Measured: 2 years
Procedural success
Attainment of <30% residual stenosis of the target lesion and no in-hospital device-oriented composite end-points (DOCE) as defined above at 1 month and 6 months and annually to 3 years and its individual components.
Measured: 3 years
Stent thrombosis
Stent thrombosis according to ARC definition at all time points.
Measured: 2 years
Bleeding
The composite of BARC 3 or 5 bleeding at 24 months according to BARC definition. The individual bleeding events (BARC 1, 2, 3, 4 and 5) according to the BARC definition
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 818 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS National Waiting Times Centre Board
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation, Venn Life Sciences, Cardialysis B.V., Diagram B.V.
- Responsible party
- Principal investigator, Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303717
- Sponsor's protocol ID
- IRAS Project ID162820
- Acronym
- IDEAL-LM
- Status last verified
- Nov 2014
- First submitted
- 19 Nov 2014
- Last updated
- 1 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Drug Eluting Stent for Percutaneous Coronary Intervention of the Left Main Artery in a Real World All-comers Population
- ClinicalTrials.gov ID
- NCT02303717
- Acronym / sponsor ID
- IDEAL-LM / IRAS Project ID162820
- Conditions
- Coronary Artery Disease
- Keywords
- Left main, PCI, DES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 818 participants (estimated)
- Lead sponsor
- NHS National Waiting Times Centre BoardUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation, Venn Life Sciences, Cardialysis B.V., Diagram B.V.
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Dec 2014 (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.
A prospective, randomized, multicenter study in patients with an indication for coronary artery revascularisation who have been accepted for percutaneous coronary intervention (PCI) of the left main coronary artery. Patients will undergo standard PCI of the left main coronary artery and will be randomized in a 1:1 fashion to the Synergy stent or to the XIENCE stent. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy arm whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100 patients will have control angiography with Optical Coherence Tomography (OCT) at t=3 months after treatment.
Detailed description
PCI of the left main coronary artery is a complex procedure with increased risk of both short and long-term major cardiac adverse events. With the use of coronary artery stents the outcome has significant improved and PCI of the left main is included in the European Society Cardiology guidelines [8]. However the results of first generation drug eluting stents still show significant room for improvement, as the risk of very late stent thrombosis has been shown to accrue up to 5 year follow-up. The newest generation of drug eluting stents have improved radial strength with thinner strut thickness, bioresorbable coatings for local drug delivery which are resorbed in 3 months and are applied only direct to the vessel wall. These stents have been evaluated in non-complex disease with good results. A comparison of the newest generation drug eluting stents in combination with a short duration of dual antiplatelet therapy versus current standard PCI techniques in complex PCI of left main coronary artery disease is therefore desirable.
The study stent (Synergy) is an evolution of currently used drug eluting stents and in initial trials demonstrated similar results for surrogate endpoints [4,5] On clinical endpoints no difference has been demonstrated. This results in a very small possibility of inferiority to current stents where re-intervention is the largest risk. For shortening DAPT several non-randomized studies have shown high safety with a very low risk (1%) of stent thrombosis [6]. Based on the improved properties of the study stent (biodegradable coating) the risk of early DAPT discontinuation should be minimal. For the relevant subgroup control coronary angiography with the additional use of OCT imaging can be considered a standard procedure with a very low risk of major complications (0.4%) [7] This study will investigate the short term angiographic and long term clinical outcome of after implantation of an improved drug eluting coronary artery stent (Everolimus-eluting Platinum Chromium Stent with Abluminal Bioabsorbable Polymer) with shorter post interventional dual antiplatelet therapy (DAPT) in comparison to a conventional drug eluting stent with a permanent Polymer followed by 12 months DAPT for treatment of unprotected left main coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xience | Active comparator | Device: Percutaneous coronary intervention, Drug: Dual antiplatelet therapyPercutaneous coronary intervention utilising a cobalt chromium everolimus eluting stent with durable polymer (Xience) plus oral dual antiplatelet therapy (DAPT) for 12 months. DAPT will be aspirin 75-100mg daily plus either clopidogrel 75mg daily or prasugrel 5-10mg daily or ticagrelor 90mg twice daily. |
| Synergy | Experimental | Device: Percutaneous coronary intervention, Drug: Dual antiplatelet therapyPercutaneous coronary intervention utilising a platinum chromium everolimus eluting stent with bioresorbable polymer (Synergy) plus oral dual antiplatelet therapy (DAPT) for 4 months. DAPT will be aspirin 75-100mg daily plus either clopidogrel 75mg daily or prasugrel 5-10mg daily or ticagrelor 90mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with an indication for coronary artery revascularisation by ESC guidelines and accepted for PCI of the left main coronary artery will be included in the study.
- Patient has an indication for coronary artery revascularisation of the left main artery in accordance with the ESC guidelines
- Patient has been discussed with the cardiac surgeon prior to PCI procedure
- Patient is accepted for PCI
- Patient is at least 18 years of age.
Key exclusion criteria (11 listed)
- Not able to receive anti-platelet treatment due to contraindications
- Known allergy to acetylsalicylic acid, clopidogrel, prasugrel or ticagrelor
- Cardiogenic shock
- STEMI within the last 5 days
- Planned surgery within 12 months after stent introduction
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 |
|---|---|---|
| Percutaneous coronary interventionAlso: PCIPercutaneous coronary stent implantation | Device | Synergy, Xience |
| Dual antiplatelet therapyAlso: DAPTDual antiplatelet therapy with aspirin and either clopidogrel, prasugrel or ticagrelor will be recommended for 12 months duration in the Xience stent arm but only 4 months duration in the Synergy stent arm. | Drug | Synergy, Xience |
Primary outcome
MACE
Time frame: 2 years
The primary endpoint is the rate of MACE defined as death from any cause or MI or ischemia-driven target vessel revascularization (TVR) at 2 years after the procedure.
7 secondary outcomes
All cause mortality
Time frame: 2 years
MI
Time frame: 2 years
Ischaemia driven target vessel revascularisation
Time frame: 2 years
Procedural success
Time frame: 2 years
Procedural success
Time frame: 3 years
Stent thrombosis
Time frame: 2 years
Bleeding
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention and Dual antiplatelet therapy in people with Coronary Artery Disease, run by NHS National Waiting Times Centre Board.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith G Oldroyd, MB ChB (+44 141 951 5180, keith.oldroyd@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 2 years). 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 1 Dec 2014.