AzTrials
AzTrials

Coronary DiseasePhase 4EXecutiveNCT00531011

EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease

A Phase 4 study testing XIENCE V® Everolimus Eluting Coronary Stent System and TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 24 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease (MVD). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
XIENCE V® Everolimus Eluting Coronary Stent System and TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
24 sitesItaly
Study dates
Sep 2007to Jun 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patient must be at least 18 years of age
  • Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
  • Patient has been diagnosed a MVD, as documented by coronary angiography, i.e. presenting a severe stenosis (>50%) amenable to PCI in at least 2 major epicardial vessels or their principal bifurcation branches (diagonal or obtuse marginal)
  • Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram -ECG- consistent with ischemia)
  • Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  • Patient must agree to undergo all protocol-required follow-up examinations.
Show all 13Show fewer
  • Angiographic Inclusion Criteria
  • Patients may receive up to 4 planned XIENCE V® EECSS stents, depending on the number of vessels treated and their respective lesion length. When multiple lesions are present in one or more main coronary branches, complete revascularization should be attempted with the implantation of a maximum of 4 planned stents
  • Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
  • Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
  • Target lesion < or = 28 mm in length by visual estimation
  • Target lesions must be in a major artery or its principal branches (diagonal or obtuse marginal) with a visually estimated stenosis of > or = 50%
  • Two lesions in a single main coronary artery or its branches do not constitute a MVD situation, therefore this type of patient must not be enrolled

Who cannot join

  • Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (non-procedural/spontaneous MI, CK-MB > or = to 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure
  • Patient has current unstable arrhythmias
  • Patient has a known left ventricular ejection fraction (LVEF) <30%
  • Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  • Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
  • Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
Show all 22Show fewer
  • Patient is receiving chronic anticoagulation therapy (e.g. coumadin)
  • Patient has a known hypersensitivity or contraindication to aspirin, paclitaxel, either heparin or bivalirudin, clopidogrel or ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
  • Elective surgery is planned within the first 9 months (+/- 14 days) after the procedure that will require discontinuing either aspirin or clopidogrel
  • Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dl, patient on dialysis)
  • Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  • Patient has had a significant GI or urinary bleed within the past six months
  • Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
  • Patient is already participating in another investigational use device or drug study or has completed the follow-up phase of another study within the last 30 days.
  • Angiographic Exclusion Criteria
  • Target lesion meets any of the following criteria:
  • Left main location
  • Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and >20% stenosed lesion by visual estimation)
  • Heavy calcification
  • The patient may need more than 4 planned stents. Bailout stents are allowed but must be of the same type as randomization stent.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Italy24 sites

  • A.O. San Giovanni di Dio

    Agrigento

  • Ospedale Maggiore Bologna

    Bologna

  • Policlinico S. Orsola - Malpighi

    Bologna

  • A.O. Cannizzaro

    Catania

  • A.O. Universitaria Vittorio Emanuele - Ferrarotto - S. Bambino

    Catania

  • A.O. Università Mater Domini c/o Campus Università Magna Grecia

    Catanzaro

  • A.O. Universitaria OO.RR Foggia

    Foggia

  • E.O. Ospedali Galliera

    Genova

  • A.O. Carlo Poma

    Mantua

  • Centro Cardiologico Monzino

    Milan

  • Ospedale Loreto Mare

    Naples

  • A. O. Sant'Andrea

    Roma

  • Ospedale Generale Madre Vannini

    Roma

  • Ospedale Sandro Pertini

    Roma

  • A.S.O. Molinette San Giovanni Battista di Torino

    Torino

  • Ospedale Maria Vittoria

    Torino

  • P.O. San Giovanni Bosco

    Torino

  • San Giovanni Battista - Ospedale Molinette

    Torino

  • A.O. Universitaria - Ospedale Riuniti Umberto I - G.M. Lancisi - G. Salesi

    Torrette Di Ancona

  • Ospedale Civile Maggiore - Università di Verona

    Verona, 37142

  • Ospedale Civile

    Vicenza

  • Ospedale Civile di Vigevano

    Vigevano

  • A.O. Della Provincia di Pavia

    Voghera

  • Policlinico San Marco

    Zingonia

Other trials in Italy

About this study

Official title: EXecutive Randomized Controlled Trial (RCT): XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the Treatment of the Specific Setting of Patients With Multi-vessel Coronary Artery Disease.

The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease (MVD).

Read the detailed description

This is a clinical evaluation of the XIENCE V® everolimus eluting coronary stent system as a revascularization treatment of patients with multi-vessel coronary artery disease (MVD-CAD).

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were consistently lower than the comparator arm of each study.

The post approval EXECUTIVE study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the EXECUTIVE trial.

The study is composed of two parts:

A Registry, outlined in a separate posting and the Randomized Control Trial (RCT) portion of this study, which is as follows:

-A randomized group of patients aimed at assessing the angiographic efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) compared to the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System.

Being tested
XIENCE V® Everolimus Eluting Coronary Stent System, TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Keywords
Stents, Drug-eluting Stent, Angioplasty, Coronary Artery stenosis, Coronary Artery Stent Restenosis, Stent Thrombosis
Medical subject headings
Coronary Disease, Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XIENCE V® Everolimus Eluting Coronary Stent SystemDevice

    Coronary artery placement of a drug-eluting stent

  • TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent SystemDevice

    Coronary artery placement of a drug-eluting stent

Study groups in NCT00531011
Study groupRoleWhat they receive
XIENCE VActive comparatorPatients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
Receives: Device: XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® Liberté™Active comparatorPatients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Receives: Device: TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-stent Late Loss (LL)

    Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.

    Measured: at 270 days

Secondary outcomes (18)

  1. In-stent Binary Restenosis Rate

    This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges.

    Measured: at 9 months

  2. In-segment Binary Restenosis Rate

    This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges

    In-segment is measured within the confines of the stent edges plus within 5 mm on either side of the stent.

    Measured: at 9 months

  3. In-segment Late Loss (LL)

    LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In segment LL is measured within the confines of the stent edges and within 5 mm of those edges.

    Measured: at 9 months

  4. Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) .

    This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.

    Measured: at 30 days

  5. Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR).

    Measured: at 30 days

  6. Lesion Success

    defined as attainment of < 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.

    Measured: at the time of PCI

  7. Procedural Success

    defined as: residual in-stent %DS of < 30% using a percutaneous method, without cardiac death, Q-wave MI, non Q-wave MI, or repeat revasc of the target during hospitalization.

    Measured: at the time of PCI

  8. Device Success

    defined as achievement of a final residual in-stent diameter stenosis of < 30% (visual assessment) using the assigned device only.

    Measured: at the time of PCI

  9. Adjudicated Stent Thrombosis.

    Measured: at 30 days

  10. Adjudicated Stent Thrombosis.

    Measured: 9 months

  11. Revascularizations

    (TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.

    Measured: at 30 days

  12. Revascularizations

    (TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.

    Measured: 9 months

  13. Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR .

    ITT

    Measured: 9 months

  14. Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR.

    Measured: 9 months

  15. In-stent Minimum Lumen Diameter (MLD).

    Measured: at 9 months.

  16. In-segment Minimum Lumen Diameter (MLD).

    Measured: at 9 months.

  17. Proximal Minimum Lumen Diameter (MLD).

    Proximal refers to the immediate 5 mm outside of the proximal end of the stent.

    Measured: at 9 months.

  18. Distal Minimum Lumen Diameter (MLD).

    Distal refers to the immediate 5 mm outside of the distal end of the stent.

    Measured: at 9 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionMar 2010
  4. Study completionJun 2011

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00531011
Sponsor's protocol ID
07-380 RCT
Acronym
EXecutive
Status last verified
May 2015
First submitted
14 Sep 2007
Last updated
8 Jun 2015
Data monitoring committee
No

Publications

  • Ribichini F, Romano M, Rosiello R, La Vecchia L, Cabianca E, Caramanno G, Milazzo D, Loschiavo P, Rigattieri S, Musaro S, Pironi B, Fiscella A, Amico F, Indolfi C, Spaccarotella C, Bartorelli A, Trabattoni D, Della Rovere F, Rolandi A, Beqaraj F, Belli R, Sangiorgio P, Villani R, Berni A, Sheiban I, Lopera Quijada MJ, Cappi B, Ribaldi L, Vassanelli C; EXECUTIVE Trial Investigators. A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease: the EXECUTIVE trial (EXecutive RCT: evaluating XIENCE V in a multi vessel disease). JACC Cardiovasc Interv. 2013 Oct;6(10):1012-22. doi: 10.1016/j.jcin.2013.05.016. Epub 2013 Sep 18.

    PubMed 24055444

  • Ribichini F, Ansalone G, Bartorelli A, Beqaraj F, Berni A, Colangelo S, D'Amico M, Della Rovere F, Fiscella A, Gabrielli G, Indolfi C, La Vecchia L, Loschiavo P, Marinoni G, Marzocchi A, Milazzo D, Romano M, Sangiorgio P, Sheiban I, Tamburino C, Tuccillo B, Villani R, Cappi B, Quijada MJ, Vassanelli C; EXECUTIVE Trial Investigators. A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease. Study design and rationale of the EXECUTIVE trial. J Cardiovasc Med (Hagerstown). 2010 Apr;11(4):299-309. doi: 10.2459/JCM.0b013e3283331e69.

    PubMed 20090550

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing XIENCE V® Everolimus Eluting Coronary Stent System and TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 24 sites in Italy.

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 13 inclusion and 22 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Italy. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

In-stent Late Loss (LL) (time frame: at 270 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00531011, which also lists 2 linked publications.

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 8 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in