The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00180310




Registration number
NCT00180310
Ethics application status
Date submitted
11/09/2005
Date registered
11/09/2005
Date last updated
18/07/2011

Titles & IDs
Public title
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Scientific title
A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Secondary ID [1] 0 0
03-364
Universal Trial Number (UTN)
Trial acronym
SPIRIT II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - XIENCE V® Everolimus Eluting Coronary Stent
Treatment: Devices - TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Experimental: 1 - XIENCE V® Everolimus Eluting Coronary Stent System

Active Comparator: 2 - TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent


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

Treatment: Devices: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
In-stent late loss (LL)
Timepoint [1] 0 0
at 180 days
Secondary outcome [1] 0 0
In-segment Late Loss
Timepoint [1] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [2] 0 0
In-stent Late Loss at 2 years (for a subset of 152 patients)
Timepoint [2] 0 0
at 2 years (for a subset of 152 patients)
Secondary outcome [3] 0 0
Proximal and distal Late Loss
Timepoint [3] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [4] 0 0
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
Timepoint [4] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [5] 0 0
In-stent and in-segment percent Diameter Stenosis (% DS)
Timepoint [5] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [6] 0 0
In-stent percent Volume Obstruction (% VO)
Timepoint [6] 0 0
at 180 days and at 2 years for a subset of 152 patients
Secondary outcome [7] 0 0
Plaque behind the stent( by IVUS)
Timepoint [7] 0 0
at 180 days and at 2 years for a subset of 152 patients
Secondary outcome [8] 0 0
Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate
Timepoint [8] 0 0
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Secondary outcome [9] 0 0
Ischemia Driven Target Vessel Failure (ID-TVF)
Timepoint [9] 0 0
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Secondary outcome [10] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [10] 0 0
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Secondary outcome [11] 0 0
Persisting incomplete stent apposition, late-acquired incomplete stent apposition
Timepoint [11] 0 0
at 180 days and at 2 years for a subset of 152 patients
Secondary outcome [12] 0 0
Aneurysm, thrombosis and persisting dissection
Timepoint [12] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [13] 0 0
Acute success(device, procedure and clinical)
Timepoint [13] 0 0
Acute

Eligibility
Key inclusion criteria
- De novo Target lesion(s) must be located in a native epicardial vessel with diameter
between 2.25 mm and 4.25 mm by visual estimate

- The target lesion(s) must be in a major artery or branch with a visually estimated
stenosis of >= 50% and < 100% with a TIMI flow of >= 1

- Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if
done >= 90 days prior to the index procedure or if planned to be done > 9 months after
the index procedure
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- De novo target lesion(s) located in a major epicardial vessel or a side branch that
has been previously treated with any type of percutaneous intervention (e.g., balloon
angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure

- Target lesion(s) restenotic from previous intervention

- Target lesion(s) located in a major epicardial vessel that has been previously treated
with brachytherapy

- Target vessel(s) contains visible thrombus

- Patient has a high probability that a procedure other than pre-dilatation, stenting
and post-dilatation will be required at the time of index procedure for treatment of
the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

- Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a
target vessel or side branch for which an intervention within 9 months after the index
procedure may be required

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerpen
Country [3] 0 0
Belgium
State/province [3] 0 0
Liège
Country [4] 0 0
Denmark
State/province [4] 0 0
Aalborg
Country [5] 0 0
Denmark
State/province [5] 0 0
Aarhus
Country [6] 0 0
Denmark
State/province [6] 0 0
Copenhagen
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Rouen
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
France
State/province [10] 0 0
Tours
Country [11] 0 0
Germany
State/province [11] 0 0
Bad Oeynhausen
Country [12] 0 0
Germany
State/province [12] 0 0
Bad Segeberg
Country [13] 0 0
Germany
State/province [13] 0 0
Dachau
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Kassel
Country [16] 0 0
India
State/province [16] 0 0
New Delhi
Country [17] 0 0
Italy
State/province [17] 0 0
Reggio Emilia
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Netherlands
State/province [19] 0 0
Breda
Country [20] 0 0
Netherlands
State/province [20] 0 0
Nieuwegein
Country [21] 0 0
Netherlands
State/province [21] 0 0
Rotterdam
Country [22] 0 0
Netherlands
State/province [22] 0 0
Zwolle
Country [23] 0 0
New Zealand
State/province [23] 0 0
Epsom
Country [24] 0 0
New Zealand
State/province [24] 0 0
Grafton
Country [25] 0 0
Poland
State/province [25] 0 0
Warsaw
Country [26] 0 0
South Africa
State/province [26] 0 0
Cape Town
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Switzerland
State/province [28] 0 0
Basel
Country [29] 0 0
Switzerland
State/province [29] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical
trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved
commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
System.

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston
Scientific.
Trial website
https://clinicaltrials.gov/show/NCT00180310
Trial related presentations / publications
Garg S, Serruys P, Onuma Y, Dorange C, Veldhof S, Miquel-Hébert K, Sudhir K, Boland J, Huber K, Garcia E, te Riele JA; SPIRIT II Investigators. 3-year clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT II trial (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009 Dec;2(12):1190-8. doi: 10.1016/j.jcin.2009.10.002.
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Serruys
Address 0 0
Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications