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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402272
• Other study ID #: 05-369
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2006
• Last updated: October 13, 2010
• Start date: November 2006
• Est. completion date: June 2010

Study information

• Verified date: October 2010
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2700
• Est. completion date: June 2010
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  China,  Czech Republic,  France,  Germany,  Greece,  India,  Ireland,  Israel,  Italy,  Malaysia,  Netherlands,  New Zealand,  Portugal,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .		at 30 days	Yes
Secondary	SPIRIT V Registry: Acute Success (Clinical Procedure Success)		Acute	Yes
Secondary	SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)		at 30 days, 1 and 2 years	Yes
Secondary	SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)		at 30 days, 1 and 2 years	Yes
Secondary	SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR		at 30 days, 1 and 2 years	Yes
Secondary	SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR		at 30 days, 1 and 2 years	Yes
Secondary	SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)		at 30 days, 1 and 2 years	Yes
Secondary	SPIRIT V Registry: Acute Success (Clinical Device Success)		Acute	Yes