NCT01182428

Brief 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.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
455

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2008

Typical duration for phase_4

Geographic Reach
15 countries

25 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, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 13, 2012

Completed
Last Updated

August 7, 2012

Status Verified

July 1, 2012

Enrollment Period

2.4 years

First QC Date

July 13, 2010

Results QC Date

May 3, 2012

Last Update Submit

July 23, 2012

Conditions

Coronary Artery StenosisCoronary ArteriosclerosisCoronary Artery DiseaseCoronary Artery RestenosisTotal Coronary OcclusionStent ThrombosisVascular DiseaseMyocardial Ischemia

Keywords

StentsAngioplastyTotal coronary occlusionsCoronary restenosisStent thrombosisEverolimus

Outcome Measures

Primary Outcomes (2)

  • Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).

    This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.

    at 1 year

  • In-stent Late Loss (LL) (Main Secondary Endpoint)

    In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.

    at 270 days

Secondary Outcomes (28)

  • Clinical Device Success

    Intra-operative

  • Clinical Procedure Success

    Intra-operative

  • Adjudicated Stent Thrombosis (Definite, Probable)

    < 1 day (Acute)

  • Adjudicated Stent Thrombosis (Definite, Probable)

    1 to 30 days (Sub-Acute)

  • Adjudicated Stent Thrombosis (Definite, Probable)

    30 days to 1 year (Late)

  • +23 more secondary outcomes

Study Arms (2)

XIENCE V® / XIENCE PRIME™

EXPERIMENTAL
Device: XIENCE V®/ XIENCE PRIME™

CYPHER SELECT

ACTIVE COMPARATOR
Device: CYPHER SELECT

Interventions

XIENCE V®/ XIENCE PRIME™DEVICE

Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System

XIENCE V® / XIENCE PRIME™
CYPHER SELECTDEVICE

XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions

CYPHER SELECT

Eligibility Criteria

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

You may qualify if:

  • Patient must be female.
  • Patient must be at least 18 years of age.
  • Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or 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 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 of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
  • Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study 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. 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.

You may not qualify if:

  • 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 clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
  • Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  • Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
  • Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon.
  • Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Hosital Italiano de Buenos Aires - Cardiologia

Buenos Aires, Buenos Aires, 1181, Argentina

Location

Instituto Cardiovascular de Buenos Aires-ICBA

Buenos Aires, 1428, Argentina

Location

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

Vienna, 1090, Austria

Location

Heilig Hart Ziekenhuis Roeselare

Roeselare, 8800, Belgium

Location

Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

São Paulo, 04012-180, Brazil

Location

Rigshospitalet

Copenhagen, Denmark

Location

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

Massy, 91300, France

Location

Kardiologische Klinik Herz- und Diabeteszentrum

Bad Oeynhausen, 32545, Germany

Location

Segebergerkliniken

Bad Segeberg, 23795, Germany

Location

Technische Universität Dresden, Medizinische Klinik II - Kardiologie

Dresden, 01307, Germany

Location

Semmelweis University, Department of Cardiovascular Surgery

Budapest, Hungary

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

Milan, 20149, Italy

Location

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

Modena, 41100, Italy

Location

Ospedale Cisanello

Pisa, 56127, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Latvian Center of Cardiology, P. Stradina University Hospital

Riga, 1002, Latvia

Location

AMC

Amsterdam, 1105, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3430, Netherlands

Location

Haukeland university hospital

Bergen, 5021, Norway

Location

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Hospital General de Alicante

Alicante, 3010, Spain

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Inselspital Bern, Kardiologie

Bern, 3010, Switzerland

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Related Publications (2)

  • Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.

    PMID: 19072483BACKGROUND

  • Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferre JM, Strasser R, Grinfeld L, Heg D, Juni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.

    PMID: 28796809DERIVED

MeSH Terms

Conditions

Coronary StenosisCoronary Artery DiseaseCoronary RestenosisVascular DiseasesMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Results Point of Contact

Title
Ellen Travis, Clinical Science
Organization
Abbott Vascular
Ellen.Travis@av.abbott.com
408-845-3000

Study Officials

  • Marie-Claude Morice

    Institut Cardiovasculaire Paris Sud (ICPS), Paris, France

    PRINCIPAL INVESTIGATOR

  • Stephan Windecker

    University Hospital Bern, Bern, Switzerland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2010

First Posted

August 16, 2010

Study Start

September 1, 2008

Primary Completion

February 1, 2011

Study Completion

July 1, 2011

Last Updated

August 7, 2012

Results First Posted

July 13, 2012

Record last verified: 2012-07

Locations

NO(1)AU(1)BE(1)DE(3)IT(5)HU(1)AR(2)LA(1)FR(1)BR(1)DK(1)PL(1)CH(2)NL(2)ES(2)