SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00180479
First received: September 13, 2005
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

This study is divided into 5 arms:

  1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System
  2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
  3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
  4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
  5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan

The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.


Condition Intervention Phase
Stents
Coronary Artery Disease
Total Coronary Occlusion
Coronary Artery Restenosis
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
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: SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Primary Endpoint: In-segment Late Loss (LL) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.


Secondary Outcome Measures:
  • Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death (death in which a cardiac cause cannot be excluded)
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
    • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

  • Target Vessel Failure (TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death (death in which a cardiac cause cannot be excluded)
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
    • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

  • Target Vessel Failure (TVF) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

    The composite endpoint comprised of:

    • Cardiac death (death in which a cardiac cause cannot be excluded)
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
    • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

  • Target Vessel Failure (TVF) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    The composite endpoint comprised of:

    • Cardiac death (death in which a cardiac cause cannot be excluded)
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
    • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

  • Target Vessel Failure (TVF) [ Time Frame: 2 year ] [ Designated as safety issue: No ]

    The composite endpoint comprised of:

    • Cardiac death (death in which a cardiac cause cannot be excluded)
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
    • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

  • Target Vessel Failure (TVF) [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death (death in which a cardiac cause cannot be excluded)
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
    • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

  • Target Vessel Failure (TVF) [ Time Frame: 4 year ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death (death in which a cardiac cause cannot be excluded)
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
    • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    Revascularization @ target lesion associated w/ any of following:

    (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study


  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

    Revascularization @ target lesion associated w/ any of following:

    (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study


  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 270 days ] [ Designated as safety issue: No ]

    Revascularization @ target lesion associated w/ any of following:

    (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study


  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 1 years ] [ Designated as safety issue: No ]

    Revascularization @ target lesion associated w/ any of following:

    (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study


  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    Revascularization @ target lesion associated w/ any of following:

    (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study


  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 3 year ] [ Designated as safety issue: No ]

    Revascularization @ target lesion associated w/ any of following:

    (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study


  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 4 year ] [ Designated as safety issue: No ]

    Revascularization @ target lesion associated w/ any of following:

    (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study


  • Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    Revascularization at the target vessel associated with any of the following

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

    Derived from Non-Hierarchical Subject Counts of Adverse Events


  • Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

    Revascularization at the target vessel associated with any of the following

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

    Derived from Non-Hierarchical Subject Counts of Adverse Events


  • Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]

    Revascularization at the target vessel associated with any of the following

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

    Derived from Non-Hierarchical Subject Counts of Adverse Events


  • Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Revascularization at the target vessel associated with any of the following

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

    Derived from Non-Hierarchical Subject Counts of Adverse Events


  • Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    Revascularization at the target vessel associated with any of the following

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

    Derived from Non-Hierarchical Subject Counts of Adverse Events


  • Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    Revascularization at the target vessel associated with any of the following

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

    Derived from Non-Hierarchical Subject Counts of Adverse Events


  • Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    Revascularization at the target vessel associated with any of the following

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

    Derived from Non-Hierarchical Subject Counts of Adverse Events


  • Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

  • Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

  • Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

  • Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

  • Ischemia Driven Major Adverse Cardiac Event(MACE) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

  • Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

  • Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 4 year ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

  • In-stent % Angiographic Binary Restenosis (% ABR) Rate [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
    Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)

  • In-segment % Angiographic Binary Restenosis (% ABR) Rate [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA

  • Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection [ Time Frame: at 240 days ] [ Designated as safety issue: No ]

    Incomplete Apposition (Persisting & Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol & ARC definition.

    Persisting dissection @ follow-up, present post-procedure.


  • Acute Success: Clinical Device [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
    Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.

  • Acute Success: Clinical Procedure [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
    Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.

  • Proximal Late Loss [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
    Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)

  • Distal Late Loss [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)

  • In-stent Late Loss [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
    In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)

  • % Volume Obstruction (% VO) [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
    Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.

  • In-stent % Diameter Stenosis (% DS) [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
    In-stent: Within the margins of the stent, the value calculated as 100 * (1 - in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  • In-segment % Diameter Stenosis (% DS) [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 - in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  • Target Vessel Failure (TVF) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death (death in which a cardiac cause cannot be excluded)
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
    • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    Revascularization @ target lesion associated w/ any of following:

    (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study


  • Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    Revascularization at the target vessel associated with any of the following

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

    Derived from Non-Hierarchical Subject Counts of Adverse Events


  • Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    The composite endpoint comprised of:

    • Cardiac death
    • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI


Enrollment: 1002
Study Start Date: June 2005
Study Completion Date: November 2011
Primary Completion Date: December 2006 (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 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm
  • The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (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 (subjects who received brachytherapy will be excluded from the trial)

Exclusion Criteria:

  • Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
  • Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation
  • Located in a major epicardial vessel that has been previously treated with brachytherapy
  • Located in a major epicardial vessel that has been previously treated with percutaneous intervention < 9 months prior to index procedure
  • Total occlusion (TIMI flow 0), prior to wire passing
  • The target vessel contains thrombus
  • Another significant lesion (> 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion
  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: NCT00180479

  Show 65 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Gregg W Stone, MD Columbia University
  More Information

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

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00180479     History of Changes
Other Study ID Numbers: 03-360
Study First Received: September 13, 2005
Results First Received: October 15, 2008
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Everolimus

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Thrombosis
Vascular Diseases
Coronary Occlusion
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Embolism and Thrombosis
Everolimus
Sirolimus
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on July 24, 2014