Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00402272
Other study ID # 05-369
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A