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NCT Number: NCT00180479

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

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.

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Key information

Conditions

Stents Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Restenosis Coronary Artery Stenosis Coronary Disease Coronary Restenosis Coronary Stenosis Heart Diseases Myocardial Ischemia Stent Thrombosis Total Coronary Occlusion Vascular Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Baptist Health System - Montclair, Birmingham, Alabama, United States

Loading trial locations.

About this study

The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS (XIENCE V® arm) will be compared to an active control group represented by the FDA approved commercially available Boston Scientific TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System (TAXUS® arm).

The SPIRIT III clinical trial consists of a randomized clinical trial (RCT) in the US which will enroll approximately 1,002 subjects (2:1 randomization XIENCE V® EECS : TAXUS® EXPRESS2™ PECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 3.75 mm.

The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms (2.25 mm diameter stent, 4.0 mm diameter stent and 38 mm length stent arms) and one Japanese non-randomized arm as follows:

  • 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 2.25 mm and < 2.5 mm and lesion length <= 22 mm will be enrolled concurrently in the US 2.25 mm non-randomized treatment arm
  • 80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.75 mm and >= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the US 4.0 mm non-randomized treatment arm
  • 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.0 mm and < 4.25 mm and lesion length > 24 mm and < 32 mm will be enrolled concurrently in the US 38 mm non-randomized treatment arm.
  • 88 Japanese subjects with a maximum of two de novo native coronary artery lesions within vessel sizes >= 2.5 mm and <= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the non-randomized Japanese arm.

All subjects in the RCT and the four non-randomized arms will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the TAXUS® arm of US RCT.

Subjects enrolled in the US RCT will be sub-grouped based on whether they will have an angiographic and/or an intravascular ultrasound (IVUS) follow-up at 240 days as follows:

Group A: Angiographic and IVUS follow-up at 240 days (N=240) Group B: Angiographic follow-up at 240 days (N=324) Group C: No angiographic or IVUS follow-up (N=438)

All subjects will have clinical follow-up at 30, 180, 240 and 270 days (Data collected through 270 days will be submitted as the primary data set for US and Japanese market approval), and 1, 2, 3, 4, and 5 years (for annual reports).

All subjects enrolled into three US non-randomized arms (N=105 for 2.25 mm arm, N=80 for 4.0 mm arm and N=105 for 38 mm stent arm) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic follow-up at 240 days. No IVUS follow-up is required for subjects enrolled in these arms.

All subjects enrolled into the Japanese non-randomized arm (N=88) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic and IVUS follow-up at 240 days.

All subjects who receive a bailout stent will be assigned to Group A follow-up subgroup (angiographic and IVUS follow-up at 240 days after the index procedure), regardless of their primary assignment at randomization. At sites without IVUS capability, subjects receiving bailout stent will be assigned to Group B follow-up subgroup (angiographic follow-up at 240 days after the index procedure). Angiographic follow-up is required for all bailout subjects at 240 days.

Data from the US RCT will be submitted to the FDA as the primary data set for product approval for RVD >= 2.5 mm and <= 3.75 mm (2.5 mm, 3.0 mm and 3.5 mm stents). Combined data of the US trial/Japanese non-randomized arm will be submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Japanese approval for RVD>=2.5 mm and <= 4.25 mm (2.5 mm, 3.0 mm 3.5 mm and 4.0 mm stents). Data from the Japanese non-randomized arm will be submitted to the FDA as additional safety data. Data from the US non-randomized arms of the trial will be the primary data sets for approval for 2.25 mm diameter stent (RVD > 2.25 mm and < 2.5 mm), 4.0 mm diameter stent (RVD > 3.75 mm and <= 4.25 mm) and 38 mm length stent (RVD > 3.0 mm and <= 4.25 mm and lesion length > 24 mm and <= 32 mm), respectively in the US.

A pharmacokinetic substudy will be carried out in a minimum of 5 pre-determined sites in the US and a minimum of 5 pre-determined sites in Japan. In the US, the pharmacokinetics (PK) of everolimus, as delivered by the XIENCE V® EECS will be analyzed in a subset of 15 subjects (minimum) with single vessel/lesion treatment, and up to 20 subjects with dual vessel/lesion treatment, respectively. In Japan, a minimum of 10 subjects with single vessel/lesion treatment and up to 20 subjects with dual vessel/lesion treatment will have a PK measurements performed. These subsets will include subjects receiving overlapping stents.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XIENCE V® Everolimus Eluting Coronary Stent

Device

Drug eluting stent implantation stent in the treatment of coronary artery disease.

Other names: XIENCE V® Everolimus Eluting Coronary Stent System

TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent

Device

Drug eluting stent implantation stent in the treatment of coronary artery disease.

Other names: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System

Primary outcomes

  1. Primary Endpoint: In-segment Late Loss (LL)

    Time frame: 240 days

    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 outcomes

  1. Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)

    Time frame: 270 days

    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

  2. Target Vessel Failure (TVF)

    Time frame: 30 days

    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

  3. Target Vessel Failure (TVF)

    Time frame: 180 days

    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

  4. Target Vessel Failure (TVF)

    Time frame: 1 year

    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

  5. Target Vessel Failure (TVF)

    Time frame: 2 year

    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

  6. Target Vessel Failure (TVF)

    Time frame: 3 year

    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

  7. Target Vessel Failure (TVF)

    Time frame: 4 year

    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

  8. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 30 days

    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

  9. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 180 days

    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

  10. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 270 days

    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

  11. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 1 years

    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

  12. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 2 years

    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

  13. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 3 year

    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

  14. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 4 year

    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

  15. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 30 days

    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

  16. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 180 days

    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

  17. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 270 days

    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

  18. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 1 year

    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

  19. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 2 years

    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

  20. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 3 years

    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

  21. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 4 years

    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

  22. Ischemia Driven Major Adverse Cardiac Event (MACE)

    Time frame: 30 days

    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

  23. Ischemia Driven Major Adverse Cardiac Event (MACE)

    Time frame: 180 days

    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

  24. Ischemia Driven Major Adverse Cardiac Event (MACE)

    Time frame: 270 days

    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

  25. Ischemia Driven Major Adverse Cardiac Event (MACE)

    Time frame: 1 year

    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

  26. Ischemia Driven Major Adverse Cardiac Event(MACE)

    Time frame: 2 years

    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

  27. Ischemia Driven Major Adverse Cardiac Event (MACE)

    Time frame: 3 year

    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

  28. Ischemia Driven Major Adverse Cardiac Event (MACE)

    Time frame: 4 year

    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

  29. In-stent % Angiographic Binary Restenosis (% ABR) Rate

    Time frame: at 240 days

    Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)

  30. In-segment % Angiographic Binary Restenosis (% ABR) Rate

    Time frame: 240 days

    Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA

  31. Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection

    Time frame: at 240 days

    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.

  32. Acute Success: Clinical Device

    Time frame: In-hospital

    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%.

  33. Acute Success: Clinical Procedure

    Time frame: In-hospital

    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%.

  34. Proximal Late Loss

    Time frame: at 240 days

    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)

  35. Distal Late Loss

    Time frame: 240 days

    Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)

  36. In-stent Late Loss

    Time frame: at 240 days

    In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)

  37. % Volume Obstruction (% VO)

    Time frame: at 240 days

    Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.

  38. In-stent % Diameter Stenosis (% DS)

    Time frame: at 240 days

    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.

  39. In-segment % Diameter Stenosis (% DS)

    Time frame: 240 days

    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.

  40. Target Vessel Failure (TVF)

    Time frame: 5 years

    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

  41. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 5 years

    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

  42. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 5 years

    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

  43. Ischemia Driven Major Adverse Cardiac Event (MACE)

    Time frame: 5 years

    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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2011
First posted
Sep 16, 2005
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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