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Trial record 1 of 1 for:    NCT00180310
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SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System (SPIRIT II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180310
First Posted: September 16, 2005
Last Update Posted: July 20, 2011
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott Vascular
  Purpose

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.


Condition Intervention Phase
Coronary Disease Coronary Artery Disease Coronary Restenosis Device: XIENCE V® Everolimus Eluting Coronary Stent Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • In-stent late loss (LL) [ Time Frame: at 180 days ]

Secondary Outcome Measures:
  • In-segment Late Loss [ Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients) ]
  • In-stent Late Loss at 2 years (for a subset of 152 patients) [ Time Frame: at 2 years (for a subset of 152 patients) ]
  • Proximal and distal Late Loss [ Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients) ]
  • 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) ]
  • 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) ]
  • In-stent percent Volume Obstruction (% VO) [ Time Frame: at 180 days and at 2 years for a subset of 152 patients ]
  • Plaque behind the stent( by IVUS) [ Time Frame: at 180 days and at 2 years for a subset of 152 patients ]
  • Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate [ Time Frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years ]
  • Ischemia Driven Target Vessel Failure (ID-TVF) [ Time Frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years ]
  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years ]
  • Persisting incomplete stent apposition, late-acquired incomplete stent apposition [ Time Frame: at 180 days and at 2 years for a subset of 152 patients ]
  • Aneurysm, thrombosis and persisting dissection [ Time Frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients) ]
  • Acute success(device, procedure and clinical) [ Time Frame: Acute ]

Enrollment: 300
Study Start Date: July 2005
Study Completion Date: February 2011
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: XIENCE V® Everolimus Eluting Coronary Stent System
Active Comparator: 2
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180310


  Show 32 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Patrick Serruys Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
  More Information

Publications:
SPIRIT II study: A clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions. Serruys Patrick W (Reprint). Erasmus MC, Ctr Thorax, Rotterdam, Netherlands. Journal of the American College of Cardiology 51 ( 10, Suppl. A ): p A261 MAR 11 2008
A clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with cle novo native coronary artery lesions. Ruygrok Peter(Reprint). Auckland City Hosp, Auckland, New Zealand Journal: Journal of the American College of Cardiology 49 ( 9, Suppl. B ): p 28B-29B MAR 6 2007 2007 i2 Summit 2007 on Innovation in Intervention New Orleans, LA, USA March 24 -27, 2007; 20070324 ISSN: 0735-1097
A clinical evaluation of the XIENCE V Everolimus Eluting CSS in the treatment of patients with de novo, native coronary artery lesions. Pharmaco kinetic substudy. Seth A (Reprint); Neuzner J; Richardt G; Wiemer M; Piek J J; Desaga M; Macaya C; Serruys P W; Spirit II Investigators (Reprint) Author Address: Max Hosp, Vasc Inst, New Delhi, India. European Heart Journal 27 ( Suppl. 1 ): p 767 AUG 2006 2006 World Congress of Cardiology Barcelona, SPAIN September 02 -06, 2006; 20060902 ISSN: 0195-668X Document Type: Meeting; Meeting Poster
Serruys, P. SPIRIT II Clinical Study: A clinical evaluation of the XIENCE™ V Everolimus Eluting CSS in the treatment of patients with de novo, native coronary artery lesions - IVUS substudy. Transcatheter Cardiovascular Therapeutics - TCT Congress 2006

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kathleen Peeters, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00180310     History of Changes
Other Study ID Numbers: 03-364
First Submitted: September 11, 2005
First Posted: September 16, 2005
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Abbott Vascular:
drug eluting stents
stents
angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Paclitaxel
Albumin-Bound Paclitaxel
Everolimus
Sirolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents