SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System (SPIRIT II)

July 18, 2011 updated by: Abbott Medical Devices

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

Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System.

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

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
      • Vienna, Austria, 1160
        • Wilheminenspital der Stadt Wien
  • Belgium
      • Antwerpen, Belgium, 2020
        • A.Z. Middelheim
      • Liège, Belgium, 4000
        • C.H.R. La Citadelle
      • Liège, Belgium, 4000
        • C.H.U. de Liège Sart Tilman
  • Denmark
      • Aalborg, Denmark
        • Aalborg Sygehus Syd
      • Aarhus, Denmark
        • Århus University Hospital
      • Copenhagen, Denmark
        • Rigshospitalet
  • France
      • Paris, France
        • Hôpital Cochin
      • Rouen, France
        • Clinique Saint Hilaire
      • Toulouse, France
        • Clinique Pasteur
      • Toulouse, France
        • Hopital De Rangueil CHU
      • Tours, France
        • Clinique Saint Gatien
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Herzzentrum Bad Oeynhausen
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken GmbH
      • Dachau, Germany
        • Amper Kliniken AG Klinikum Dachau
      • Hamburg, Germany
        • Herz- und Gefäßzentrum Hamburg
      • Kassel, Germany
        • Klinikum Kassel
  • India
      • New Delhi, India, 110017
        • Max Devki Devi Heart & Vascular Institute
  • Italy
      • Reggio Emilia, Italy
        • Azienda Ospedaliera Santa Maria Nuova
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Breda, Netherlands
        • Amphia Hospital
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis Nieuwegein
      • Rotterdam, Netherlands
        • Erasmus Medical Center
      • Zwolle, Netherlands
        • Isala Klinieken - Locatie Weezenlanden
  • New Zealand
    • Epsom
      • Auckland, Epsom, New Zealand
        • The Mercy Hospital
    • Grafton
      • Auckland, Grafton, New Zealand
        • Auckland City Hospital
  • Poland
      • Warsaw, Poland
        • National Institute of Cardiology in Warsaw
  • South Africa
      • Cape Town, South Africa
        • Vergelegen Mediclinic
  • Spain
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • University Hospital Gregorio Marañon
  • Switzerland
      • Basel, Switzerland
        • Kantonsspital Basel
      • Geneva, Switzerland
        • R.V. Hôpital Cantonal Universitaire de Geneve

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:

  • De novo Target lesion(s) must be located in a native epicardial vessel with diameter between 2.25 mm and 4.25 mm by visual estimate
  • The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a TIMI flow of >= 1
  • Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure or if planned to be done > 9 months after the index procedure

Exclusion Criteria:

  • De novo target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure
  • Target lesion(s) restenotic from previous intervention
  • Target lesion(s) located in a major epicardial vessel that has been previously treated with brachytherapy
  • Target vessel(s) contains visible thrombus
  • Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
  • Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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
Active Comparator: 2
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease
Other Names:
  • TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-stent late loss (LL)
Time Frame: at 180 days
at 180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
In-segment Late Loss
Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients)
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent Late Loss at 2 years (for a subset of 152 patients)
Time Frame: at 2 years (for a subset of 152 patients)
at 2 years (for a subset of 152 patients)
Proximal and distal Late Loss
Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients)
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients)
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent and in-segment percent Diameter Stenosis (% DS)
Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients)
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent percent Volume Obstruction (% VO)
Time Frame: at 180 days and at 2 years for a subset of 152 patients
at 180 days and at 2 years for a subset of 152 patients
Plaque behind the stent( by IVUS)
Time Frame: at 180 days and at 2 years for a subset of 152 patients
at 180 days and at 2 years for a subset of 152 patients
Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate
Time Frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Ischemia Driven Target Vessel Failure (ID-TVF)
Time Frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Persisting incomplete stent apposition, late-acquired incomplete stent apposition
Time Frame: at 180 days and at 2 years for a subset of 152 patients
at 180 days and at 2 years for a subset of 152 patients
Aneurysm, thrombosis and persisting dissection
Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients)
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Acute success(device, procedure and clinical)
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: Patrick Serruys, Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands

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

July 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 18, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-364

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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