SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe (SPIRIT V)

October 13, 2010 updated by: Abbott Medical Devices

SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry.

The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating performance of the XIENCE V® EECSS in real-world use, per its Instruction For Use (IFU). 2,700 patients will be enrolled in the SPIRIT V Registry.

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 V Registry study after 2 years.

Study Type

Interventional

Enrollment (Actual)

2700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • Salzburger Landeskliniken
  • Belgium
      • Brussels, Belgium
        • UCL St Luc
      • Brussels, Belgium
        • ULB Erasmus Hospital
      • Gent, Belgium
        • UZ Gent
      • Gilly, Belgium
        • Hôpital St Joseph
      • Namur, Belgium
        • Clinique St. Luc - Bouge
  • Canada
      • Calgary, Canada
        • Foothills Medical Center
      • Montreal, Canada
        • Montreal Heart Institute
      • Montreal, Canada
        • CHUM Hotel Dieu Hospital
      • Ottawa, Canada
        • University of Ottawa Heart Institute
      • Quebec, Canada
        • Hôpital Laval
      • Toronto, Canada
        • Sunnybrook and Women's College
      • Toronto, Canada
        • University health Network - Toronto Gen Hospital
  • China
      • Beijing, China
        • Fuwai Hospital
      • Hong Kong, China
        • Prince of Wales Hospital
      • Hong Kong, China
        • PYNEH
      • Hong Kong, China
        • Queen Elizabeth
      • Shangai, China
        • Zhongshan Hospital
  • Czech Republic
      • Karlove, Czech Republic
        • Univerzity Hospital Hradec Králové
  • France
      • Grenoble, France
        • C.H.U. - Hopital Michallon
      • Lille, France
        • CHU Lille - Hôpital Cardiologique
      • Nantes, France
        • NCN - Nouvelle Cliniques Nantaises
      • Nimes, France
        • Hopital privé Les Fransiscaines
      • Paris, France
        • La Pitié Salpêtrière
      • Rennes, France
        • Polyclinique St Laurent
      • Saint Denis, France
        • C.C.N.
  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff Klinik GmbH
      • Bernau, Germany
        • Herzzentrum
      • Heidelberg, Germany
        • Universitätsklinikum
      • Neuss, Germany
        • Lukas Krankenhaus Neuss
      • Siegburg, Germany, 53721
        • Herzzentrum Siegburg GMBH
      • Ulm, Germany
        • Universitätsklinikum Ulm
      • Wuppertal, Germany
        • Helios Klinikum Wuppertal
  • Greece
      • Athens, Greece
        • Onassis Cardiac Center
  • India
      • Ahmedabad, India
        • Krishna Heart Institute
      • Chennai, India
        • Apollo Hospital
      • Chennai, India
        • Institute of Cardiovascular Disease M.M.M.
      • Delhi, India
        • All India Institute of Medical Science - AIIMS
      • Delhi, India
        • Fortis Hospital
      • Kolkata, India
        • B M Birla
      • New Delhi, India
        • Kailash Hospital
      • Pune, India
        • Ruby Hall Clinic
  • Ireland
      • Dublin, Ireland
        • Beaumont Hospital
      • Galway, Ireland
        • University Hospital Galway
  • Israel
      • Jerusalem, Israel
        • Hadassah-Hebrew University Medical Center
      • Ramat Gan, Israel
        • Sheba Medical Center
      • Tel-Aviv, Israel
        • Ichilov Medical Center
  • Italy
      • Arezzo, Italy
        • Azienda USL 8
      • Bergamo, Italy
        • Azienda Ospedaliera Riuniti
      • Brescia, Italy
        • Emodinamica Azienda Spedali Civili
      • Cagliari, Italy
        • Azienda Ospedaliera G. Brotzu
      • Mestre, Italy
        • Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1
      • Mirano, Italy
        • Ospedale Civile
      • Padova, Italy
        • Azienda Ospedaliera di Padova
      • Pavia, Italy
        • IRCCS Policlinico San Matteo
      • Roma, Italy
        • Ospedale San Filippo Neri
      • Roma, Italy
        • Policlinico A. Gemelli
      • Salerno, Italy
        • Azienda Ospedaliera S. Gdi Dio Salerno
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institute Jantung Negara
      • Kuching, Malaysia
        • Sarawak General Hospital
  • Netherlands
      • Alkmaar, Netherlands
        • Medisch Centrum Alkmaar
      • Eindhoven, Netherlands
        • Catharina ZH Eindhoven
      • Rotterdam, Netherlands
        • Maasstad Ziekenhuis
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
  • Portugal
      • Lisboa, Portugal
        • Hospital Santa Marta
      • Lisbon, Portugal
        • Hospital Santa Cruz
      • Lisbon, Portugal
        • Hospital Garcia da Orta
  • Singapore
      • Singapore, Singapore
        • National University Hospital
  • South Africa
      • Johannesburg, South Africa
        • Sunninghill Hospital
      • Vergelegen, South Africa
        • Vergelegen Clinic
  • Spain
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Universitari de Bellvigte
      • Barcelona, Spain
        • Trias Y Pujol
      • Barcelona, Spain
        • Valle Hebron
      • Cadiz, Spain
        • Puerta del mar
      • Madrid, Spain
        • Hospital Puerta de Hierro
      • Madrid, Spain
        • Clinico San Carlos
      • Madrid, Spain
        • La Paz
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Palma de Mallorca, Spain
        • Hospital Son Dureta
      • San Sebastian, Spain
        • Policlinica Gipuzkoa
      • Santander, Spain
        • Marques de Valdecilla
      • Vigo, Spain
        • Meixoeiro-Medtec
  • Sweden
      • Uppsala, Sweden
        • Uppsala Univ. Hospital
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
  • Thailand
      • Bangkok, Thailand
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand
        • Bhumibol Adulyadej Hospital
  • United Kingdom
      • Brighton, United Kingdom
        • Royal Sussex County, Brighton
      • Leicester, United Kingdom
        • Glenfield Hospital
      • London, United Kingdom
        • King's College Hospital
      • Manchester, United Kingdom
        • Wythenshawe Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Wessex Cardiac Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years
  • 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
  • evidence of myocardial ischemia
  • acceptable candidate for coronary artery bypass graft (CABG) surgery
  • undergo all CIP-required follow-up examinations
  • artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC
  • target lesions must be de novo lesions
  • target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
  • target lesion ≤ 28 mm in length by visual estimate

Exclusion Criteria:

Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
XIENCE V® Everolimus Eluting Coronary Stent System
Device: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Other Names:
  • XIENCE V® Everolimus Eluting Coronary Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .
Time Frame: at 30 days
at 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
SPIRIT V Registry: Acute Success (Clinical Procedure Success)
Time Frame: Acute
Acute
SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)
Time Frame: at 30 days, 1 and 2 years
at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)
Time Frame: at 30 days, 1 and 2 years
at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR
Time Frame: at 30 days, 1 and 2 years
at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR
Time Frame: at 30 days, 1 and 2 years
at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)
Time Frame: at 30 days, 1 and 2 years
at 30 days, 1 and 2 years
SPIRIT V Registry: Acute Success (Clinical Device Success)
Time Frame: Acute
Acute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Eberhard Grube, MD, The Heart Center, Siegburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

November 17, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (ESTIMATE)

November 22, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2010

Last Update Submitted That Met QC Criteria

October 13, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-369

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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