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SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00180310
First received: September 11, 2005
Last updated: July 18, 2011
Last verified: July 2011
History of Changes

September 11, 2005
July 18, 2011
July 2005
July 2007   (final data collection date for primary outcome measure)
In-stent late loss (LL) [ Time Frame: at 180 days ] [ Designated as safety issue: Yes ]
· In-stent late loss (LL) at 180 days
Complete list of historical versions of study NCT00180310 on ClinicalTrials.gov Archive Site
  • In-segment Late Loss [ Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients) ] [ Designated as safety issue: Yes ]
  • In-stent Late Loss at 2 years (for a subset of 152 patients) [ Time Frame: at 2 years (for a subset of 152 patients) ] [ Designated as safety issue: Yes ]
  • Proximal and distal Late Loss [ Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients) ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment Angiographic Binary Restenosis (ABR) rate [ Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients) ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment percent Diameter Stenosis (% DS) [ Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients) ] [ Designated as safety issue: Yes ]
  • In-stent percent Volume Obstruction (% VO) [ Time Frame: at 180 days and at 2 years for a subset of 152 patients ] [ Designated as safety issue: Yes ]
  • Plaque behind the stent( by IVUS) [ Time Frame: at 180 days and at 2 years for a subset of 152 patients ] [ Designated as safety issue: Yes ]
  • Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate [ Time Frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Ischemia Driven Target Vessel Failure (ID-TVF) [ Time Frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Persisting incomplete stent apposition, late-acquired incomplete stent apposition [ Time Frame: at 180 days and at 2 years for a subset of 152 patients ] [ Designated as safety issue: Yes ]
  • Aneurysm, thrombosis and persisting dissection [ Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients) ] [ Designated as safety issue: Yes ]
  • Acute success(device, procedure and clinical) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
  • · Ischemia driven Target Vessel Failure (TVF) at 30, 180, 270 days, and 1 and 2 years
  • · Ischemia driven target lesion revascularization (TLR) at 30, 180, 270 days, and 1 and 2 years
  • · Ischemia driven major adverse cardiac event (MACE) at 30, 180, 270 days, and 1 and 2 years
  • · Proximal and distal LL at 180 days and 2 years*
  • · In-segment LL at 180 days and 2 years*
  • · In-stent LL at 2 years*
  • · In-stent and in-segment % angiographic binary restenosis (% ABR) rate at 180 days and 2 years*
  • · In-stent % volume obstruction (% VO) at 180 days and 2 years
  • **angiographic followup at 2 years only for a subset of 152 patients
Not Provided
Not Provided
 
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions

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.

The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis
  • Device: XIENCE V® Everolimus Eluting Coronary Stent
    Drug eluting stent implantation stent in the treatment of coronary artery disease.
    Other Name: XIENCE V® Everolimus Eluting Coronary Stent System
  • Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
    Drug eluting stent implantation stent in the treatment of coronary artery disease
    Other Name: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
  • Experimental: 1
    XIENCE V® Everolimus Eluting Coronary Stent System
    Intervention: Device: XIENCE V® Everolimus Eluting Coronary Stent
  • Active Comparator: 2
    TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
    Intervention: Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
February 2011
July 2007   (final data collection date for primary outcome measure)

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

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   France,   Germany,   India,   Italy,   Netherlands,   New Zealand,   Poland,   South Africa,   Spain,   Switzerland
 
NCT00180310
03-364
Yes
Kathleen Peeters, Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: Patrick Serruys Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
Abbott Vascular
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP