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Completed

NCT Number: NCT01178268

XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during commercial use in China.

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Key information

Conditions

Coronary Occlusion Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Stenosis Coronary Disease Coronary Restenosis Coronary Stenosis Embolism and Thrombosis Heart Diseases Myocardial Ischemia Thrombosis Thrombosis (Stent Thrombosis) Vascular Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fu Wai Hospital, Beijing, China

Loading trial locations.

About this study

Objectives

  • Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China
  • Evaluate patient compliance with dual antiplatelet therapy (DAPT)
  • Evaluate physician-determined XIENCE V EECSS acute performance, deliverability, and resource utilization

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • General Inclusion Criteria
  • Patient must be at least 18 years of age
  • The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee (EC)-approved ICF prior to procedure.
  • Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.
  • Patient must not currently be and must agree not to become a participant in any other clinical trial until completion of his/her 2-year follow-up.

Angiographic Inclusion Criteria

  • Target lesion(s) must be located in a native de novo coronary artery with a visually estimated diameter between ≥ 2.25 and ≤ 4.0 mm.
  • Target lesion(s) must measure ≤ 28 mm in length by visual estimation.
  • A maximum of two de novo lesions can be treated, ie,
  • One lesion in one vessel, OR
  • One lesion in each of two vessels, OR
  • Two lesions in one vessel

Exclusion criteria

  • General Exclusion Criteria
  • Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure
  • Patients with known renal insufficiency or failure (eg, serum creatinine level of > 2.5 mg/dL, or patient is on dialysis)
  • Patient had an MI within 72 hours and creatine kinase-myocardial band isoenzyme (CK-MB) has not returned to the normal range at the index procedure
  • Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure
  • Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure
  • Left ventricular ejection fraction (LVEF) of < 30%.
  • Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year
  • Patient's current medical condition has a life expectancy of < 2 years
  • Patient meets contraindications of the IFU

Angiographic Exclusion Criteria

  • Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
  • Lesion located in left main coronary artery
  • Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries)
  • Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation
  • Total occluded lesions (TIMI=0)
  • Restenotic lesions
  • Thrombus-containing vessel
  • Extreme angulation (≥ 90º) proximal to or within the lesion
  • Excessive tortuosity proximal to or within the lesion
  • Heavy calcification

Treatment and study plan

XIENCE V EECSS

Device

Patients who will receive this stent.

CYPHER SELECT PLUS SECSS

Device

Patients who will receive this stent.

Primary outcomes

  1. In-stent Late Loss (LL)

    Time frame: >=13 months

    This is the primary angiographic endpoint.

    In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)

  2. Ischemia-driven Target Vessel Failure (ID-TVF)

    Time frame: 12 months

    This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).

  3. Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)

    Time frame: 12 months

    The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave).

Secondary outcomes

  1. Ischemia-driven Target Vessel Failure (ID-TVF)

    Time frame: 30 days

    Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])

  2. Ischemia-driven Target Vessel Failure (ID-TVF)

    Time frame: 6 months

    Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]).

  3. Ischemia-driven Target Vessel Failure (ID-TVF)

    Time frame: 9 months

    Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])

  4. Ischemia-driven Target Vessel Failure (ID-TVF)

    Time frame: 24 months

    Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])

  5. Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).

    Time frame: 30 days

  6. Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).

    Time frame: 6 months

  7. Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)

    Time frame: 9 months

  8. Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)

    Time frame: 24 months

  9. Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])

    Time frame: 12 months

    The is the major Secondary Efficacy Endpoint.

  10. Ischemia-driven Target Lesion Failure (ID-TLF)

    Time frame: 30 days

    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

  11. Ischemia-driven Target Lesion Failure (ID-TLF)

    Time frame: 6 months

    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

  12. Ischemia-driven Target Lesion Failure (ID-TLF)

    Time frame: 9 months

    This is one of the Secondary Composite Endpoints.

  13. Ischemia-driven Target Lesion Failure (ID-TLF)

    Time frame: 12 months

    This is one of the Secondary Composite Endpoints.

  14. Ischemia-driven Target Lesion Failure (ID-TLF)

    Time frame: 24 months

    This is one of the Secondary Composite Endpoints.

  15. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

    Time frame: 30 days

  16. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

    Time frame: 6 months

  17. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

    Time frame: 9 months

  18. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

    Time frame: 12 months

  19. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

    Time frame: 24 months

  20. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)

    Time frame: 30 days

    This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].

  21. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)

    Time frame: 6 months

    This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].

  22. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)

    Time frame: 9 months

    This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].

  23. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)

    Time frame: 12 months

    This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].

  24. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)

    Time frame: 24 months

    This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].

  25. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

    Time frame: 30 days

  26. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

    Time frame: 6 months

  27. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

    Time frame: 9 months

  28. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

    Time frame: 12 months

  29. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

    Time frame: 24 months

  30. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

    Time frame: 30 days

  31. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

    Time frame: 6 months

  32. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

    Time frame: 9 months

  33. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

    Time frame: 12 months

  34. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

    Time frame: 24 months

  35. All Revascularization (TLR, TVR, and Non-TVR)

    Time frame: 30 Days

  36. All Revascularization (TLR, TVR, and Non-TVR)

    Time frame: 6 Months

  37. All Revascularization (TLR, TVR, and Non-TVR)

    Time frame: 9 Months

  38. All Revascularization (TLR, TVR, and Non-TVR)

    Time frame: 12 months

  39. All Revascularization (TLR, TVR, and Non-TVR)

    Time frame: 24 months

    One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).

  40. All Death

    Time frame: 30 days

    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  41. All Death

    Time frame: 6 months

    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  42. All Death

    Time frame: 9 months

    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  43. All Death

    Time frame: 12 months

    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  44. All Death

    Time frame: 24 months

    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  45. All Protocol MI (Including Q-wave or Non-Q-wave)

    Time frame: 30 days

    This is one of the secondary safety endpoint.

  46. All Protocol MI (Including Q-wave or Non-Q-wave)

    Time frame: 6 months

    This is one of the secondary safety endpoint.

  47. All Protocol MI (Including Q-wave or Non-Q-wave)

    Time frame: 9 months

    This is one of the secondary safety endpoint.

  48. All Protocol MI (Including Q-wave or Non-Q-wave)

    Time frame: 12 months

    This is one of the secondary safety endpoint.

  49. All Protocol MI (Including Q-wave or Non-Q-wave)

    Time frame: 24 months

    This is one of the secondary safety endpoint.

  50. Target Vessel Protocol MI (TV-MI)

    Time frame: 30 days

    This is one of the secondary safety endpoint.

  51. Target Vessel Protocol MI (TV-MI)

    Time frame: 6 months

    This is one of the secondary safety endpoint.

  52. Target Vessel Protocol MI (TV-MI)

    Time frame: 9 months

    This is one of the secondary safety endpoint.

  53. Target Vessel Protocol MI (TV-MI)

    Time frame: 12 months

    This is one of the secondary safety endpoint.

  54. Target Vessel Protocol MI (TV-MI)

    Time frame: 24 months

    This is one of the secondary safety endpoint.

  55. Major Bleeding Complications

    Time frame: 30 days

    Secondary safety endpoint.

  56. Major Bleeding Complications

    Time frame: 6 months

    Secondary safety endpoint.

  57. Major Bleeding Complications

    Time frame: 9 months

    Secondary safety endpoint.

  58. Major Bleeding Complications

    Time frame: 12 months

    Secondary safety endpoint.

  59. Major Bleeding Complications

    Time frame: 24 months

    Secondary safety endpoint.

  60. Definite / Probable Stent Thrombosis

    Time frame: Acute (<1 day)

    Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

  61. Definite / Probable Stent Thrombosis

    Time frame: Subacute (1 - 30 days)

    Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

  62. Definite / Probable Stent Thrombosis

    Time frame: Early (0 - 30 days)

    Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

  63. Definite / Probable Stent Thrombosis

    Time frame: Late (31 - 365 days)

    Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

  64. Definite / Probable Stent Thrombosis

    Time frame: Very late (366 - 772 days)

    Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

  65. Definite / Probable Stent Thrombosis

    Time frame: Overall (0 - 772 days)

    Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

  66. Patient Compliance With Dual Antiplatelet Therapy (DAPT)

    Time frame: 30 days

  67. Patient Compliance With Dual Antiplatelet Therapy (DAPT)

    Time frame: 6 months

  68. Patient Compliance With Dual Antiplatelet Therapy (DAPT)

    Time frame: 9 months

  69. Patient Compliance With Dual Antiplatelet Therapy (DAPT)

    Time frame: 12 months

  70. Patient Compliance With Dual Antiplatelet Therapy (DAPT)

    Time frame: 24 months

  71. Acute Device Success

    Time frame: < or = 1 day

    Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of < 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.

  72. Acute Procedure Success

    Time frame: < or = 1 day

    Per-protocol procedure success is defined as the achievement of a final in-stent DS of < 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non-Q-wave), or repeat revascularization of the target lesion during the hospital stay.

  73. Procedure Time

    Time frame: On day 0, during the procedure.

    This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.

  74. Amount of Contrast Used

    Time frame: On day 0, during the procedure.

    Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.

  75. Fluoroscopy Time

    Time frame: On day 0, during the procedure.

    This is the procedure related endpoint.

  76. XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire

    Time frame: During the procedure

    A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure.

  77. Follow-up Late Loss

    Time frame: ≥13 months.

    This is one of the Secondary Angiographic Endpoint.

  78. Follow-up In-stent Minimum Lumen Diameter (MLD)

    Time frame: ≥13 months

  79. Follow-up In-stent Percent Diameter Stenosis (DS)

    Time frame: ≥13 months

  80. Follow-up In-stent Angiographic Binary Restenosis (ABR)

    Time frame: ≥13 months

  81. Follow-up In-segment Minimum Lumen Diameter (MLD)

    Time frame: ≥13 months

  82. Follow-up In-segment Percent Diameter Stenosis (DS)

    Time frame: ≥13 months

  83. Follow-up In-segment Angiographic Binary Restenosis (ABR)

    Time frame: ≥13 months

  84. Percent Diameter Stenosis

    Time frame: pre procedure

  85. Percent Diameter Stenosis (%DS)

    Time frame: post procedure on 0 day

  86. Acute Gain

    Time frame: post procedure on 0 day

Other outcomes

  1. ID-TVF Rate in Patients With Diabetic Disease

    Time frame: 24 months

    ID-TVF rate in All Diabetes patients.

  2. ID-TVF Rate in Patients Without Diabetic Disease

    Time frame: 24 months

    ID-TVF rate in Non Diabetes

  3. ID-TVF Rate in Single Lesion Treated Subgroup

    Time frame: 24 months

    ID-TVF rate in Patients with single lesion treated during the index procedure

  4. ID-TVF Rate in Dual Lesion Treated Subgroup

    Time frame: 24 months

    ID-TVF rate in Patients with dual lesion treated during the index procedure

  5. ID-TVF Rate in Single Vessel Treated Subgroup

    Time frame: 24 months

    ID-TVF rate in Patients with single vessels treated during the index procedure.

  6. ID-TVF Rate in Dual Vessel Treated Subgroup

    Time frame: 24 months

    ID-TVF rate in Patients with dual vessel treated during the index procedure.

  7. The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.

    Time frame: 24 months

    The composite of ST, all death, and all MI rate in All Diabetes patients.

  8. The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease

    Time frame: 24 months

    The composite of ST, all death, and all MI rate in Non Diabetes

  9. The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup

    Time frame: 24 months

    The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure

  10. The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup

    Time frame: 24 months

    The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure

  11. The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup

    Time frame: 24 months

    The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.

  12. The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup

    Time frame: 24 months

    The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.

  13. ID-TLR Rate in Patients With Diabetic Disease.

    Time frame: 24 months

    Ischemia-driven target lesion revascularization rate in All Diabetes patients.

  14. ID-TLR Rate in Patients Without Diabetic Disease

    Time frame: 24 months

    Ischemia-driven target lesion revascularization rate in Non Diabetes

  15. ID-TLR Rate in Single Lesion Treated Subgroup

    Time frame: 24 months

    Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure

  16. ID-TLR Rate in Dual Lesion Treated Subgroup

    Time frame: 24 months

    Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure

  17. ID-TLR Rate in Single Vessel Treated Subgroup

    Time frame: 24 months

    Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.

  18. ID-TLR Rate in Dual Vessel Treated Subgroup

    Time frame: 24 months

    Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Aug 10, 2010
Registry last updated
Aug 24, 2016

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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