NCT00531011

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 15, 2011

Completed
Last Updated

June 8, 2015

Status Verified

May 1, 2015

Enrollment Period

2.5 years

First QC Date

September 14, 2007

Results QC Date

May 16, 2011

Last Update Submit

May 12, 2015

Conditions

Coronary DiseaseCoronary Artery DiseaseCoronary Artery StenosisCoronary Artery Restenosis

Keywords

StentsDrug-eluting StentAngioplastyCoronary Artery stenosisCoronary Artery Stent RestenosisStent Thrombosis

Outcome Measures

Primary Outcomes (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.

    at 270 days

Secondary Outcomes (18)

  • In-stent Binary Restenosis Rate

    at 9 months

  • In-segment Binary Restenosis Rate

    at 9 months

  • In-segment Late Loss (LL)

    at 9 months

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

    at 30 days

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

    at 30 days

  • +13 more secondary outcomes

Study Arms (2)

XIENCE V

ACTIVE COMPARATOR

Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)

Device: XIENCE V® Everolimus Eluting Coronary Stent System

TAXUS® Liberté™

ACTIVE COMPARATOR

Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System

Device: TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System

Interventions

XIENCE V® Everolimus Eluting Coronary Stent SystemDEVICE

Coronary artery placement of a drug-eluting stent

XIENCE V
TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent SystemDEVICE

Coronary artery placement of a drug-eluting stent

TAXUS® Liberté™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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.)
  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

A.O. San Giovanni di Dio

Agrigento, Italy

Location

Ospedale Maggiore Bologna

Bologna, Italy

Location

Policlinico S. Orsola - Malpighi

Bologna, Italy

Location

A.O. Cannizzaro

Catania, Italy

Location

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

Catania, Italy

Location

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

Catanzaro, Italy

Location

A.O. Universitaria OO.RR Foggia

Foggia, Italy

Location

E.O. Ospedali Galliera

Genova, Italy

Location

A.O. Carlo Poma

Mantova, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Ospedale Loreto Mare

Napoli, Italy

Location

A. O. Sant'Andrea

Roma, Italy

Location

Ospedale Generale Madre Vannini

Roma, Italy

Location

Ospedale Sandro Pertini

Roma, Italy

Location

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

Torino, Italy

Location

Ospedale Maria Vittoria

Torino, Italy

Location

P.O. San Giovanni Bosco

Torino, Italy

Location

San Giovanni Battista - Ospedale Molinette

Torino, Italy

Location

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

Torrette Di Ancona, Italy

Location

Ospedale Civile Maggiore - Università di Verona

Verona, 37142, Italy

Location

Ospedale Civile

Vicenza, Italy

Location

Ospedale Civile di Vigevano

Vigevano, Italy

Location

A.O. Della Provincia di Pavia

Voghera, Italy

Location

Policlinico San Marco

Zingonia, Italy

Location

Related Publications (2)

  • 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.

    PMID: 24055444DERIVED

  • 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.

    PMID: 20090550DERIVED

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery DiseaseCoronary StenosisCoronary Restenosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Results Point of Contact

Title
Maria Jose' M. Lopera
Organization
Abbott Vascular, Italy
mariajose.lopera@av.abbott.com
+39-02-516251

Study Officials

  • Corrado Vassanelli, MD

    Ospedale Civile Maggiore - Università di Verona

    PRINCIPAL INVESTIGATOR

  • Flavio Ribichini, MD

    Ospedale Civile Maggiore - Università di Verona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2007

First Posted

September 18, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2010

Study Completion

June 1, 2011

Last Updated

June 8, 2015

Results First Posted

August 15, 2011

Record last verified: 2015-05

Locations

IT(24)