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Coronary DiseaseEXecutiveNCT01310309

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

An observational study of Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 23 sites in Italy.

Completed

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

Official record
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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?
Coronary artery placement of a drug-eluting stent
Type of treatment
Medical device
How many people
400 participants
Where
23 sitesItaly
Study dates
Sep 2007to Jun 2011
Phase
Observational
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

Study population: Patients with Multi-Vessel Coronary Artery Disease (MVD) treated with the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS).

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.
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  • 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.)
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  • 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

23 sites in 1 country.

23 sites in 1 country

Italy23 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

Other trials in Italy

About this study

Official title: EXecutive Registry: 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 sutdy is composed of two parts:

A Randomized Controlled Trial, outlined in a separate posting and the registry portion of this study, which is as follows:

-A prospective controlled registry to analyze the clinical efficacy and safety at mid and long-term follow-up in patients with MVD treated with the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS).

Being tested
Coronary artery placement of a drug-eluting stent
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.

  • Coronary artery placement of a drug-eluting stentDevice

    Coronary artery placement of a drug-eluting stent (XIENCE V® EECSS)

Study groups in NCT01310309
Study groupRoleWhat they receive
EXecutive RegistryA prospective controlled registry to analyze the clinical efficacy and safety at mid and long-term follow-up in patients with MVD treated with the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS).
Receives: Device: Coronary artery placement of a drug-eluting stent

What is being measured

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

  1. Composite endpoint of all Death, MI (Q-wave and non Q-wave), and ischemia-driven Target Vessel Revascularization (TVR) .

    Composite endpoints are endpoints made up of a range of statistical parameters.

    Measured: 12 months

Secondary outcomes (18)

  1. Adjudicated stent thrombosis

    Measured: 30 days

  2. Revascularizations (TLR/TVR/any revascularization)

    Measured: 30 days

  3. Composite endpoint of cardiac death, MI (Q-wave and non Q-wave), and ischemia-driven TLR.

    Measured: 30 days

  4. Composite endpoint of all death, MI (Q-wave and non Q-wave), and TVR.

    Measured: 30 days

  5. Device success

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

    Measured: At time of index procedure

  6. Lesion success

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

    Measured: At time of index procedure

  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 time of index procedure

  8. Adjudicated stent thrombosis

    Measured: 1 year

  9. Adjudicated stent thrombosis

    Measured: 2 years

  10. Adjudicated stent thrombosis

    Measured: at 3 years

  11. Revascularizations (TLR/TVR/any revascularization)

    Measured: 1 year

  12. Revascularizations (TLR/TVR/any revascularization)

    Measured: 2 years

  13. Revascularizations (TLR/TVR/any revascularization)

    Measured: 3 years

  14. Composite endpoint of cardiac death, MI (Q-wave and non Q-wave), and ischemia-driven TLR.

    Measured: 1 years

  15. Composite endpoint of cardiac death, MI (Q-wave and non Q-wave), and ischemia-driven TLR.

    Measured: 2 years

  16. Composite endpoint of cardiac death, MI (Q-wave and non Q-wave), and ischemia-driven TLR.

    Measured: 3 years

  17. Composite endpoint of all death, MI (Q-wave and non Q-wave), and TVR.

    Measured: 2 years

  18. Composite endpoint of all death, MI (Q-wave and non Q-wave), and TVR.

    Measured: 3 years

Timeline

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

  1. First posted8 Mar 2011 (estimated)
  2. Study startSep 2007
  3. Primary completionOct 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
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01310309
Sponsor's protocol ID
07-380 Registry
Acronym
EXecutive
Status last verified
Dec 2012
First submitted
3 Mar 2011
Last updated
21 Dec 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 23 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 21 Dec 2012. 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. 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?

Composite endpoint of all Death, MI (Q-wave and non Q-wave), and ischemia-driven Target Vessel Revascularization (TVR) . (time frame: 12 months). 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 NCT01310309.

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 21 Dec 2012.

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