XIENCE V: SPIRIT WOMEN Sub-study

Last updated: July 23, 2012
Sponsor: Abbott Medical Devices
Overall Status: Completed

Phase

4

Condition

Thrombosis

Coronary Artery Disease

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT01182428
07-377 sub-study
  • Ages > 18
  • Female

Study Summary

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

Eligibility Criteria

Inclusion

General Inclusion Criteria:

  • Patient must be female.

  • Patient must be at least 18 years of age.

  • Patient is able to verbally confirm understanding of risks, benefits and treatmentalternatives and she or her legally authorized representative provides writteninformed consent prior to any study related procedure, as approved by the appropriateMedical Ethics Committee of the respective clinical site.

  • Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,silent ischemia, positive functional study or a reversible change in theelectrocardiogram (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 of childbearing potential must have had a negative pregnancy test within 7days before treatment, and must not be nursing at the time of treatment. Angiographic Inclusion Criteria:

  • Patients' artery morphology and disease is suitable to be optimally treated with amaximum of 4 planned study stents.

  • Target lesions must be de novo lesions (no prior stent implant, no priorbrachytherapy).

  • Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate.The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.

  • Target lesion greater than or equal to 28 mm in length by visual estimate.

Exclusion

General Exclusion Criteria:

  • Patient has other medical illness (e.g., cancer or congestive heart failure) or knownhistory of substance abuse (alcohol, cocaine, heroin etc.) that may causenon-compliance with the clinical investigation plan, confound the data interpretationor is associated with a limited life expectancy (i.e., less than one year).

  • Patient has a known hypersensitivity or contraindication to aspirin, either heparin orbivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel,tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot beadequately pre-medicated.

  • Participation in another device or drug study or has completed the follow-up phase ofanother study within the last 30 days.

  • Patient who is judged to have a lesion that prevents complete inflation of anangioplasty balloon.

  • Patient has had a previous stent implant, either Bare Metal Stent (BMS) or DrugEluting Stent (DES) within the target vessel(s)

Study Design

Total Participants: 455
Study Start date:
September 01, 2008
Estimated Completion Date:
July 31, 2011

Study Description

SPIRIT Women Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions.

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 observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval SPIRIT V 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 SPIRIT Women study after 2 years.

Connect with a study center

  • Hosital Italiano de Buenos Aires - Cardiologia

    Buenos Aires, 1181
    Argentina

    Site Not Available

  • Instituto Cardiovascular de Buenos Aires-ICBA

    Buenos Aires, 1428
    Argentina

    Site Not Available

  • Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II

    Wien, 1090
    Austria

    Site Not Available

  • Heilig Hart Ziekenhuis Roeselare

    Roeselare, 8800
    Belgium

    Site Not Available

  • Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

    Sao Paulo, 04012-180
    Brazil

    Site Not Available

  • Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud

    Massy, 91300
    France

    Site Not Available

  • Kardiologische Klinik Herz- und Diabeteszentrum

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • Segebergerkliniken

    Bad Segeberg, 23795
    Germany

    Site Not Available

  • Technische Universität Dresden, Medizinische Klinik II - Kardiologie

    Dresden, 01307
    Germany

    Site Not Available

  • Semmelweis University, Department of Cardiovascular Surgery

    Budapest,
    Hungary

    Site Not Available

  • Centro Cardiologico Monzino

    Milan, 20138
    Italy

    Site Not Available

  • Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

    Milano, 20149
    Italy

    Site Not Available

  • Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena

    Modena, 41100
    Italy

    Site Not Available

  • Ospedale Cisanello

    Pisa, 56127
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Latvian Center of Cardiology, P. Stradina University Hospital

    Riga, 1002
    Latvia

    Site Not Available

  • AMC

    Amsterdam, 1105
    Netherlands

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein, 3430
    Netherlands

    Site Not Available

  • Haukeland university hospital

    Bergen, 5021
    Norway

    Site Not Available

  • Institute of Cardiology

    Warsaw, 04-628
    Poland

    Site Not Available

  • Hospital General de Alicante

    Alicante, 3010
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916
    Spain

    Site Not Available

  • Inselspital Bern, Kardiologie

    Bern, 3010
    Switzerland

    Site Not Available

  • Cardiocentro Ticino

    Lugano, 6900
    Switzerland

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.