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Trial record 2 of 3 for:    XIENCE 90

Xience Versus Synergy in Left Main PCI (IDEAL-LM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02303717
Recruitment Status : Not yet recruiting
First Posted : December 1, 2014
Last Update Posted : December 1, 2014
Sponsor:
Collaborators:
Boston Scientific Corporation
Venn Life Sciences
Cardialysis B.V.
Diagram B.V.
Information provided by (Responsible Party):
Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Percutaneous coronary intervention Drug: Dual antiplatelet therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 818 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improved Drug Eluting Stent for Percutaneous Coronary Intervention of the Left Main Artery in a Real World All-comers Population
Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Xience
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.
Device: Percutaneous coronary intervention
Percutaneous coronary stent implantation
Other Name: PCI

Drug: Dual antiplatelet therapy
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.
Other Name: DAPT

Experimental: Synergy
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.
Device: Percutaneous coronary intervention
Percutaneous coronary stent implantation
Other Name: PCI

Drug: Dual antiplatelet therapy
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.
Other Name: DAPT




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 2 years ]
    Component of the primary endpoint (MACE)

  2. MI [ Time Frame: 2 years ]
    Myocardial infarction as defined in protocol. Component of combined primary end-point (MACE)

  3. Ischaemia driven target vessel revascularisation [ Time Frame: 2 years ]
    Component of combined primary end-point (MACE)

  4. Procedural success [ Time Frame: 2 years ]
    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.).

  5. Procedural success [ Time Frame: 3 years ]
    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.

  6. Stent thrombosis [ Time Frame: 2 years ]
    Stent thrombosis according to ARC definition at all time points.

  7. Bleeding [ Time Frame: 2 years ]
    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


Other Outcome Measures:
  1. OCT derived healing score (no units) [ Time Frame: 3 months ]
    Based on 3 month OCT follow-up sub-study (n=100) OCT endpoints 3 months post-procedure (subgroup of patients) QCA parameters

  2. Combined primary end-point in patients eligible for CABG vs patients considered inoperable [ Time Frame: 2 years ]
    Secondary analysis comparing patients eligible for cardiac surgery with those deemed inoperable.

  3. Angiographic late loss (mm) [ Time Frame: 3 months ]
    Based on 3 month angiographic follow-up sub-study (n=100)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

  1. Patient has an indication for coronary artery revascularisation of the left main artery in accordance with the ESC guidelines
  2. Patient has been discussed with the cardiac surgeon prior to PCI procedure
  3. Patient is accepted for PCI
  4. Patient is at least 18 years of age.
  5. The patient understands and accepts the meaning and the aims of the study and is willing to provide written informed consent
  6. The patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.

Exclusion Criteria:

  1. Not able to receive anti-platelet treatment due to contraindications
  2. Known allergy to acetylsalicylic acid, clopidogrel, prasugrel or ticagrelor
  3. Cardiogenic shock
  4. STEMI within the last 5 days
  5. Planned surgery within 12 months after stent introduction
  6. History of bleeding diathesis or active major bleedings
  7. Major surgery within previous 15 days
  8. Current participation in another trial which has not yet reached its primary endpoint
  9. Life expectancy < 12 months
  10. Hypersensitivity or contraindication to everolimus or structurally-related compounds, cobalt, chromium, nickel, tungsten, acrylic, platinum and fluoropolymers
  11. Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303717


Contacts
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Contact: Keith G Oldroyd, MB ChB +44 141 951 5180 keith.oldroyd@nhs.net
Contact: Catherine Sinclair, PhD +44 141 951 5440 catherine.sinclair@gjnh.scot.nhs.uk

Sponsors and Collaborators
NHS National Waiting Times Centre Board
Boston Scientific Corporation
Venn Life Sciences
Cardialysis B.V.
Diagram B.V.
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Responsible Party: Prof. Keith G. Oldroyd, Consultant Cardiologist, NHS National Waiting Times Centre Board
ClinicalTrials.gov Identifier: NCT02303717    
Other Study ID Numbers: IRAS Project ID162820
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: December 1, 2014
Last Verified: November 2014
Keywords provided by Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board:
Left main
PCI
DES
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases