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

NCT00402272 | Completed Phase 4 DMC

• 1 other identifier: 05-369
• Study Type: interventional
• Target: 2,700
• Locations: 23 countries
• Sites: 93

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  at 30 days

Secondary Outcomes (7)

• SPIRIT V Registry: Acute Success (Clinical Procedure Success)

  Acute

• SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)

  at 30 days, 1 and 2 years

• SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)

  at 30 days, 1 and 2 years

• SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR

  at 30 days, 1 and 2 years

• SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR

  at 30 days, 1 and 2 years

Study Arms (1)

1

EXPERIMENTAL

XIENCE V® Everolimus Eluting Coronary Stent System

Device: XIENCE V® Everolimus Eluting Coronary Stent

Interventions

XIENCE V® Everolimus Eluting Coronary Stent DEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease.

Also known as: XIENCE V® Everolimus Eluting Coronary Stent System

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (93)

Salzburger Landeskliniken

Salzburg, Austria

Location

UCL St Luc

Brussels, Belgium

Location

ULB Erasmus Hospital

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

Hopital St Joseph

Gilly, Belgium

Location

Clinique St. Luc - Bouge

Namur, Belgium

Location

Foothills Medical Center

Calgary, Canada

Location

CHUM Hotel Dieu Hospital

Montreal, Canada

Location

Montreal Heart Institute

Montreal, Canada

Location

University of Ottawa Heart Institute

Ottawa, Canada

Location

Hôpital Laval

Québec, Canada

Location

Sunnybrook and Women's College

Toronto, Canada

Location

University health Network - Toronto Gen Hospital

Toronto, Canada

Location

Fuwai Hospital

Beijing, China

Location

Prince of Wales Hospital

Hong Kong, China

Location

PYNEH

Hong Kong, China

Location

Queen Elizabeth

Hong Kong, China

Location

Zhongshan Hospital

Shanghai, China

Location

Univerzity Hospital Hradec Králové

Karlove, Czechia

Location

C.H.U. - Hopital Michallon

Grenoble, France

Location

CHU Lille - Hôpital Cardiologique

Lille, France

Location

NCN - Nouvelle Cliniques Nantaises

Nantes, France

Location

Hopital privé Les Fransiscaines

Nîmes, France

Location

La pitié Salpétrière

Paris, France

Location

Polyclinique St Laurent

Rennes, France

Location

C.C.N.

Saint-Denis, France

Location

Kerckhoff Klinik GmbH

Bad Nauheim, Germany

Location

Herzzentrum

Bernau, Germany

Location

Universitätsklinikum

Heidelberg, Germany

Location

Lukas Krankenhaus Neuss

Neuss, Germany

Location

Herzzentrum Siegburg GmbH

Siegburg, 53721, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Helios Klinikum Wuppertal

Wuppertal, Germany

Location

Onassis Cardiac Center

Athens, Greece

Location

Krishna Heart Institute

Ahmedabad, India

Location

Apollo Hospital

Chennai, India

Location

Institute of Cardiovascular Disease M.M.M.

Chennai, India

Location

All India Institute of Medical Science - AIIMS

Delhi, India

Location

Fortis Hospital

Delhi, India

Location

B M Birla

Kolkata, India

Location

Kailash Hospital

New Delhi, India

Location

Ruby Hall Clinic

Pune, India

Location

Beaumont Hospital

Dublin, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Ichilov Medical Center

Tel Aviv, Israel

Location

Azienda USL 8

Arezzo, Italy

Location

Azienda Ospedaliera Riuniti

Bergamo, Italy

Location

Emodinamica Azienda Spedali Civili

Brescia, Italy

Location

Azienda Ospedaliera G. Brotzu

Cagliari, Italy

Location

Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1

Mestre, Italy

Location

Ospedale Civile

Mirano, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

IRCCS Policlinico San Matteo

Pavia, Italy

Location

Ospedale San Filippo Neri

Roma, Italy

Location

Policlinico A. Gemelli

Roma, Italy

Location

Azienda Ospedaliera S. Gdi Dio Salerno

Salerno, Italy

Location

Institute Jantung Negara

Kuala Lumpur, Malaysia

Location

Sarawak General Hospital

Kuching, Malaysia

Location

Medisch Centrum Alkmaar

Alkmaar, Netherlands

Location

Catharina ZH Eindhoven

Eindhoven, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Hospital Garcia da Orta

Lisbon, Portugal

Location

Hospital Santa Cruz

Lisbon, Portugal

Location

Hospital Santa Marta

Lisbon, Portugal

Location

National University Hospital

Singapore, Singapore

Location

Sunninghill Hospital

Johannesburg, South Africa

Location

Vergelegen Clinic

Vergelegen, South Africa

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, Spain

Location

Hospital Universitari de Bellvigte

Barcelona, Spain

Location

Trias Y Pujol

Barcelona, Spain

Location

Valle Hebron

Barcelona, Spain

Location

Puerta del Mar

Cadiz, Spain

Location

Policlinica Gipuzkoa

Donostia / San Sebastian, Spain

Location

Clinico San Carlos

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

La Paz

Madrid, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Spain

Location

Marques de Valdecilla

Santander, Spain

Location

Meixoeiro-Medtec

Vigo, Spain

Location

Uppsala Univ. Hospital

Uppsala, Sweden

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Bhumibol Adulyadej Hospital

Bangkok, Thailand

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Wessex Cardiac Unit

Southampton, Southampton, SO16 6YD, United Kingdom

Location

Royal Sussex County, Brighton

Brighton, United Kingdom

Location

Glenfield Hospital

Leicester, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Wythenshawe Hospital

Manchester, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 25940520 DERIVED

• 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.

  PMID: 22795276 DERIVED

• 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.

  PMID: 22607866 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Eberhard Grube, MD

  The Heart Center, Siegburg, Germany

  PRINCIPAL INVESTIGATOR

• Upendra Kaul, MD

  Fortis Hospital, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: November 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: June 1, 2010
• Last Updated: October 14, 2010

Record last verified: 2010-10

Locations

PT (3); CN (5); SE (1); AU (1); IN (8); CA (7); IE (2); IL (3); NL (3); MY (2); FR (7); DE (7); IT (11); NZ (1); CZ (1); GR (1); ES (14); CH (1); TH (2); GB (5); SG (1); ZA (2); BE (5)