Trial record 1 of 1 for:    NCT00180310
Previous Study | Return to List | Next Study

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Serruys, P., Ruygrok, P., Neuzner, J., Et al. A randomized comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: the SPIRIT II trial. EuroIntervention: 2;286-294, 2006
Ruygrok, P., Desaga, M., Van Den Branden, F., et al. One year clinical follow-up or the XIENCE V Everolimus-eluting stent system in the treatment of de novo native coronary artery lesions: the SPIRIT II study. EuroIntervention:3; 315-320, 2007.
Khattab, Ahmed A., et. al. Differentiated analysis of an evrolimus-eluting stent and a paclitaxel-eluting stent among higher risk subgroups for restenosis: results from the SPIRIT II trial. EuroIntervention 3(5): 566-573, 2008
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
Serruys, P. 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. European Society of Cardiology - ESC Congress 2006
Claessen, BE. et. al. Two Year Clinical, Angiographic and Intravascular Ultrasound Follow-Up of the XIENCE V Everolimus-Eluting Stent in the Treatment of Patients With de novo Native Coronary Artery Lesions: The SPIRIT II Trial. Circ Cardiovasc Interventions. 2009. 339-347.

Additional 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
Study First Received: September 11, 2005
Last Updated: July 18, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Everolimus
Sirolimus
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014