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

Primary Purpose

Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
XIENCE V® Everolimus Eluting Coronary Stent
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Salzburger Landeskliniken
  • UCL St Luc
  • ULB Erasmus Hospital
  • UZ Gent
  • Hopital St Joseph
  • Clinique St. Luc - Bouge
  • Foothills Medical Center
  • CHUM Hotel Dieu Hospital
  • Montreal Heart Institute
  • University of Ottawa Heart Institute
  • Hôpital Laval
  • Sunnybrook and Women's College
  • University health Network - Toronto Gen Hospital
  • Fuwai Hospital
  • Prince of Wales Hospital
  • PYNEH
  • Queen Elizabeth
  • Zhongshan Hospital
  • Univerzity Hospital Hradec Králové
  • C.H.U. - Hopital Michallon
  • CHU Lille - Hôpital Cardiologique
  • NCN - Nouvelle Cliniques Nantaises
  • Hopital privé Les Fransiscaines
  • La pitié Salpétrière
  • Polyclinique St Laurent
  • C.C.N.
  • Kerckhoff Klinik GmbH
  • Herzzentrum
  • Universitätsklinikum
  • Lukas Krankenhaus Neuss
  • Herzzentrum Siegburg GmbH
  • Universitätsklinikum Ulm
  • Helios Klinikum Wuppertal
  • Onassis Cardiac Center
  • Krishna Heart Institute
  • Apollo Hospital
  • Institute of Cardiovascular Disease M.M.M.
  • All India Institute of Medical Science - AIIMS
  • Fortis Hospital
  • B M Birla
  • Kailash Hospital
  • Ruby Hall Clinic
  • Beaumont Hospital
  • University Hospital Galway
  • Hadassah-Hebrew University Medical Center
  • Sheba Medical Center
  • Ichilov Medical Center
  • Azienda USL 8
  • Azienda Ospedaliera Riuniti
  • Emodinamica Azienda Spedali Civili
  • Azienda Ospedaliera G. Brotzu
  • Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1
  • Ospedale Civile
  • Azienda Ospedaliera di Padova
  • IRCCS Policlinico San Matteo
  • Ospedale San Filippo Neri
  • Policlinico A. Gemelli
  • Azienda Ospedaliera S. Gdi Dio Salerno
  • Institute Jantung Negara
  • Sarawak General Hospital
  • Medisch Centrum Alkmaar
  • Catharina ZH Eindhoven
  • Maasstad Ziekenhuis
  • Christchurch Hospital
  • Hospital Santa Marta
  • Hospital Garcia da Orta
  • Hospital Santa Cruz
  • National University Hospital
  • Sunninghill Hospital
  • Vergelegen Clinic
  • Hospital del Mar
  • Hospital Santa Creu I Sant Pau
  • Hospital Universitari de Bellvigte
  • Trias Y Pujol
  • Valle Hebron
  • Puerta del Mar
  • Clinico San Carlos
  • Hospital Puerta de Hierro
  • La Paz
  • Hospital Virgen de la Arrixaca
  • Hospital Son Dureta
  • Policlinica Gipuzkoa
  • Marques de Valdecilla
  • Meixoeiro-Medtec
  • Uppsala Univ. Hospital
  • Centre Hospitalier Universitaire Vaudois
  • Bhumibol Adulyadej Hospital
  • King Chulalongkorn Memorial Hospital
  • Royal Sussex County, Brighton
  • Glenfield Hospital
  • King's College Hospital
  • Wythenshawe Hospital
  • Wessex Cardiac Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

XIENCE V® Everolimus Eluting Coronary Stent System

Outcomes

Primary Outcome Measures

SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .

Secondary Outcome Measures

SPIRIT V Registry: Acute Success (Clinical Procedure Success)
SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)
SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)
SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)
SPIRIT V Registry: Acute Success (Clinical Device Success)

Full Information

First Posted
November 17, 2006
Last Updated
October 13, 2010
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00402272
Brief Title
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
Acronym
SPIRIT V
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Keywords
drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
XIENCE V® Everolimus Eluting Coronary Stent System
Intervention Type
Device
Intervention Name(s)
XIENCE V® Everolimus Eluting Coronary Stent
Other Intervention Name(s)
XIENCE V® Everolimus Eluting Coronary Stent System
Intervention Description
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Primary Outcome Measure Information:
Title
SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .
Time Frame
at 30 days
Secondary Outcome Measure Information:
Title
SPIRIT V Registry: Acute Success (Clinical Procedure Success)
Time Frame
Acute
Title
SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)
Time Frame
at 30 days, 1 and 2 years
Title
SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)
Time Frame
at 30 days, 1 and 2 years
Title
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
Title
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR
Time Frame
at 30 days, 1 and 2 years
Title
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
Title
SPIRIT V Registry: Acute Success (Clinical Device Success)
Time Frame
Acute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eberhard Grube, MD
Organizational Affiliation
The Heart Center, Siegburg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Upendra Kaul, MD
Organizational Affiliation
Fortis Hospital, New Delhi, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salzburger Landeskliniken
City
Salzburg
Country
Austria
Facility Name
UCL St Luc
City
Brussels
Country
Belgium
Facility Name
ULB Erasmus Hospital
City
Brussels
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
Hopital St Joseph
City
Gilly
Country
Belgium
Facility Name
Clinique St. Luc - Bouge
City
Namur
Country
Belgium
Facility Name
Foothills Medical Center
City
Calgary
Country
Canada
Facility Name
CHUM Hotel Dieu Hospital
City
Montreal
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
Country
Canada
Facility Name
Hôpital Laval
City
Quebec
Country
Canada
Facility Name
Sunnybrook and Women's College
City
Toronto
Country
Canada
Facility Name
University health Network - Toronto Gen Hospital
City
Toronto
Country
Canada
Facility Name
Fuwai Hospital
City
Beijing
Country
China
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
Facility Name
PYNEH
City
Hong Kong
Country
China
Facility Name
Queen Elizabeth
City
Hong Kong
Country
China
Facility Name
Zhongshan Hospital
City
Shangai
Country
China
Facility Name
Univerzity Hospital Hradec Králové
City
Karlove
Country
Czech Republic
Facility Name
C.H.U. - Hopital Michallon
City
Grenoble
Country
France
Facility Name
CHU Lille - Hôpital Cardiologique
City
Lille
Country
France
Facility Name
NCN - Nouvelle Cliniques Nantaises
City
Nantes
Country
France
Facility Name
Hopital privé Les Fransiscaines
City
Nimes
Country
France
Facility Name
La pitié Salpétrière
City
Paris
Country
France
Facility Name
Polyclinique St Laurent
City
Rennes
Country
France
Facility Name
C.C.N.
City
Saint Denis
Country
France
Facility Name
Kerckhoff Klinik GmbH
City
Bad Nauheim
Country
Germany
Facility Name
Herzzentrum
City
Bernau
Country
Germany
Facility Name
Universitätsklinikum
City
Heidelberg
Country
Germany
Facility Name
Lukas Krankenhaus Neuss
City
Neuss
Country
Germany
Facility Name
Herzzentrum Siegburg GmbH
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Helios Klinikum Wuppertal
City
Wuppertal
Country
Germany
Facility Name
Onassis Cardiac Center
City
Athens
Country
Greece
Facility Name
Krishna Heart Institute
City
Ahmedabad
Country
India
Facility Name
Apollo Hospital
City
Chennai
Country
India
Facility Name
Institute of Cardiovascular Disease M.M.M.
City
Chennai
Country
India
Facility Name
All India Institute of Medical Science - AIIMS
City
Delhi
Country
India
Facility Name
Fortis Hospital
City
Delhi
Country
India
Facility Name
B M Birla
City
Kolkata
Country
India
Facility Name
Kailash Hospital
City
New Delhi
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
Country
India
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
Facility Name
Hadassah-Hebrew University Medical Center
City
Jerusalem
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Ichilov Medical Center
City
Tel-Aviv
Country
Israel
Facility Name
Azienda USL 8
City
Arezzo
Country
Italy
Facility Name
Azienda Ospedaliera Riuniti
City
Bergamo
Country
Italy
Facility Name
Emodinamica Azienda Spedali Civili
City
Brescia
Country
Italy
Facility Name
Azienda Ospedaliera G. Brotzu
City
Cagliari
Country
Italy
Facility Name
Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1
City
Mestre
Country
Italy
Facility Name
Ospedale Civile
City
Mirano
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Ospedale San Filippo Neri
City
Roma
Country
Italy
Facility Name
Policlinico A. Gemelli
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliera S. Gdi Dio Salerno
City
Salerno
Country
Italy
Facility Name
Institute Jantung Negara
City
Kuala Lumpur
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
Country
Malaysia
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
Country
Netherlands
Facility Name
Catharina ZH Eindhoven
City
Eindhoven
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Hospital Santa Marta
City
Lisboa
Country
Portugal
Facility Name
Hospital Garcia da Orta
City
Lisbon
Country
Portugal
Facility Name
Hospital Santa Cruz
City
Lisbon
Country
Portugal
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Facility Name
Sunninghill Hospital
City
Johannesburg
Country
South Africa
Facility Name
Vergelegen Clinic
City
Vergelegen
Country
South Africa
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari de Bellvigte
City
Barcelona
Country
Spain
Facility Name
Trias Y Pujol
City
Barcelona
Country
Spain
Facility Name
Valle Hebron
City
Barcelona
Country
Spain
Facility Name
Puerta del Mar
City
Cadiz
Country
Spain
Facility Name
Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Policlinica Gipuzkoa
City
San Sebastian
Country
Spain
Facility Name
Marques de Valdecilla
City
Santander
Country
Spain
Facility Name
Meixoeiro-Medtec
City
Vigo
Country
Spain
Facility Name
Uppsala Univ. Hospital
City
Uppsala
Country
Sweden
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland
Facility Name
Bhumibol Adulyadej Hospital
City
Bangkok
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Facility Name
Royal Sussex County, Brighton
City
Brighton
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
Country
United Kingdom
Facility Name
Wessex Cardiac Unit
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25940520
Citation
Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.
Results Reference
derived
PubMed Identifier
22795276
Citation
Ringel RE, Gauvreau K, Moses H, Jenkins KJ. Coarctation of the Aorta Stent Trial (COAST): study design and rationale. Am Heart J. 2012 Jul;164(1):7-13. doi: 10.1016/j.ahj.2012.04.008. Epub 2012 Jun 20.
Results Reference
derived
PubMed Identifier
22607866
Citation
Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.
Results Reference
derived

Learn more about this trial

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

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