SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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:
|
Outcome Measures
Primary Outcome Measures
- SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) . [at 30 days]
Secondary Outcome Measures
- 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]
- 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]
- SPIRIT V Registry: Acute Success (Clinical Device Success) [Acute]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Salzburger Landeskliniken | Salzburg | Austria | ||
| 2 | UCL St Luc | Brussels | Belgium | ||
| 3 | ULB Erasmus Hospital | Brussels | Belgium | ||
| 4 | UZ Gent | Gent | Belgium | ||
| 5 | Hopital St Joseph | Gilly | Belgium | ||
| 6 | Clinique St. Luc - Bouge | Namur | Belgium | ||
| 7 | Foothills Medical Center | Calgary | Canada | ||
| 8 | CHUM Hotel Dieu Hospital | Montreal | Canada | ||
| 9 | Montreal Heart Institute | Montreal | Canada | ||
| 10 | University of Ottawa Heart Institute | Ottawa | Canada | ||
| 11 | Hôpital Laval | Quebec | Canada | ||
| 12 | Sunnybrook and Women's College | Toronto | Canada | ||
| 13 | University health Network - Toronto Gen Hospital | Toronto | Canada | ||
| 14 | Fuwai Hospital | Beijing | China | ||
| 15 | Prince of Wales Hospital | Hong Kong | China | ||
| 16 | PYNEH | Hong Kong | China | ||
| 17 | Queen Elizabeth | Hong Kong | China | ||
| 18 | Zhongshan Hospital | Shangai | China | ||
| 19 | Univerzity Hospital Hradec Králové | Karlove | Czech Republic | ||
| 20 | C.H.U. - Hopital Michallon | Grenoble | France | ||
| 21 | CHU Lille - Hôpital Cardiologique | Lille | France | ||
| 22 | NCN - Nouvelle Cliniques Nantaises | Nantes | France | ||
| 23 | Hopital privé Les Fransiscaines | Nimes | France | ||
| 24 | La pitié Salpétrière | Paris | France | ||
| 25 | Polyclinique St Laurent | Rennes | France | ||
| 26 | C.C.N. | Saint Denis | France | ||
| 27 | Kerckhoff Klinik GmbH | Bad Nauheim | Germany | ||
| 28 | Herzzentrum | Bernau | Germany | ||
| 29 | Universitätsklinikum | Heidelberg | Germany | ||
| 30 | Lukas Krankenhaus Neuss | Neuss | Germany | ||
| 31 | Herzzentrum Siegburg GmbH | Siegburg | Germany | 53721 | |
| 32 | Universitätsklinikum Ulm | Ulm | Germany | ||
| 33 | Helios Klinikum Wuppertal | Wuppertal | Germany | ||
| 34 | Onassis Cardiac Center | Athens | Greece | ||
| 35 | Krishna Heart Institute | Ahmedabad | India | ||
| 36 | Apollo Hospital | Chennai | India | ||
| 37 | Institute of Cardiovascular Disease M.M.M. | Chennai | India | ||
| 38 | All India Institute of Medical Science - AIIMS | Delhi | India | ||
| 39 | Fortis Hospital | Delhi | India | ||
| 40 | B M Birla | Kolkata | India | ||
| 41 | Kailash Hospital | New Delhi | India | ||
| 42 | Ruby Hall Clinic | Pune | India | ||
| 43 | Beaumont Hospital | Dublin | Ireland | ||
| 44 | University Hospital Galway | Galway | Ireland | ||
| 45 | Hadassah-Hebrew University Medical Center | Jerusalem | Israel | ||
| 46 | Sheba Medical Center | Ramat Gan | Israel | ||
| 47 | Ichilov Medical Center | Tel-Aviv | Israel | ||
| 48 | Azienda USL 8 | Arezzo | Italy | ||
| 49 | Azienda Ospedaliera Riuniti | Bergamo | Italy | ||
| 50 | Emodinamica Azienda Spedali Civili | Brescia | Italy | ||
| 51 | Azienda Ospedaliera G. Brotzu | Cagliari | Italy | ||
| 52 | Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1 | Mestre | Italy | ||
| 53 | Ospedale Civile | Mirano | Italy | ||
| 54 | Azienda Ospedaliera di Padova | Padova | Italy | ||
| 55 | IRCCS Policlinico San Matteo | Pavia | Italy | ||
| 56 | Ospedale San Filippo Neri | Roma | Italy | ||
| 57 | Policlinico A. Gemelli | Roma | Italy | ||
| 58 | Azienda Ospedaliera S. Gdi Dio Salerno | Salerno | Italy | ||
| 59 | Institute Jantung Negara | Kuala Lumpur | Malaysia | ||
| 60 | Sarawak General Hospital | Kuching | Malaysia | ||
| 61 | Medisch Centrum Alkmaar | Alkmaar | Netherlands | ||
| 62 | Catharina ZH Eindhoven | Eindhoven | Netherlands | ||
| 63 | Maasstad Ziekenhuis | Rotterdam | Netherlands | ||
| 64 | Christchurch Hospital | Christchurch | New Zealand | ||
| 65 | Hospital Santa Marta | Lisboa | Portugal | ||
| 66 | Hospital Garcia da Orta | Lisbon | Portugal | ||
| 67 | Hospital Santa Cruz | Lisbon | Portugal | ||
| 68 | National University Hospital | Singapore | Singapore | ||
| 69 | Sunninghill Hospital | Johannesburg | South Africa | ||
| 70 | Vergelegen Clinic | Vergelegen | South Africa | ||
| 71 | Hospital del Mar | Barcelona | Spain | ||
| 72 | Hospital Santa Creu I Sant Pau | Barcelona | Spain | ||
| 73 | Hospital Universitari de Bellvigte | Barcelona | Spain | ||
| 74 | Trias Y Pujol | Barcelona | Spain | ||
| 75 | Valle Hebron | Barcelona | Spain | ||
| 76 | Puerta del Mar | Cadiz | Spain | ||
| 77 | Clinico San Carlos | Madrid | Spain | ||
| 78 | Hospital Puerta de Hierro | Madrid | Spain | ||
| 79 | La Paz | Madrid | Spain | ||
| 80 | Hospital Virgen de la Arrixaca | Murcia | Spain | ||
| 81 | Hospital Son Dureta | Palma de Mallorca | Spain | ||
| 82 | Policlinica Gipuzkoa | San Sebastian | Spain | ||
| 83 | Marques de Valdecilla | Santander | Spain | ||
| 84 | Meixoeiro-Medtec | Vigo | Spain | ||
| 85 | Uppsala Univ. Hospital | Uppsala | Sweden | ||
| 86 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | ||
| 87 | Bhumibol Adulyadej Hospital | Bangkok | Thailand | ||
| 88 | King Chulalongkorn Memorial Hospital | Bangkok | Thailand | ||
| 89 | Royal Sussex County, Brighton | Brighton | United Kingdom | ||
| 90 | Glenfield Hospital | Leicester | United Kingdom | ||
| 91 | King's College Hospital | London | United Kingdom | ||
| 92 | Wythenshawe Hospital | Manchester | United Kingdom | ||
| 93 | Wessex Cardiac Unit | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Eberhard Grube, MD, The Heart Center, Siegburg, Germany
- Principal Investigator: Upendra Kaul, MD, Fortis Hospital, New Delhi, India
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05-369