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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Coronary Occlusion; Coronary Restenosis; Vascular Disease; Coronary Artery Stenosis; Thrombosis (Stent Thrombosis)
• Intervention / Treatment: Device: XIENCE V EECSS; Device: CYPHER SELECT PLUS SECSS

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 546
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100037
    • Fu Wai Hospital
  • Shanghai, China, 200122
    • Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• General Inclusion Criteria

  1. Patient must be at least 18 years of age
  2. 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.
  3. Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.
  4. 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

1. 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.
2. Target lesion(s) must measure ≤ 28 mm in length by visual estimation.

3. A maximum of two de novo lesions can be treated, ie,

   1. One lesion in one vessel, OR
   2. One lesion in each of two vessels, OR
   3. Two lesions in one vessel

Exclusion Criteria:

• General Exclusion Criteria

  1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure
  2. Patients with known renal insufficiency or failure (eg, serum creatinine level of > 2.5 mg/dL, or patient is on dialysis)
  3. 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
  4. Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure
  5. Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure
  6. Left ventricular ejection fraction (LVEF) of < 30%.
  7. Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year
  8. Patient's current medical condition has a life expectancy of < 2 years
  9. Patient meets contraindications of the IFU

Angiographic Exclusion Criteria

1. Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
2. Lesion located in left main coronary artery
3. Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries)
4. 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
5. Total occluded lesions (TIMI=0)
6. Restenotic lesions
7. Thrombus-containing vessel
8. Extreme angulation (≥ 90º) proximal to or within the lesion
9. Excessive tortuosity proximal to or within the lesion
10. Heavy calcification

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: XIENCE V EECSS; Patients who will receive this stent.	Device: XIENCE V EECSS; Patients who will receive this stent.
ACTIVE_COMPARATOR: CYPHER SELECT PLUS SECSS; Patients who will receive this stent.	Device: CYPHER SELECT PLUS SECSS; Patients who will receive this stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-stent Late Loss (LL)	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)	>=13 months
Ischemia-driven Target Vessel Failure (ID-TVF)	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).	12 months
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)	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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemia-driven Target Vessel Failure (ID-TVF)	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])	30 days
Ischemia-driven Target Vessel Failure (ID-TVF)	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]).	6 months
Ischemia-driven Target Vessel Failure (ID-TVF)	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])	9 months
Ischemia-driven Target Vessel Failure (ID-TVF)	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])	24 months
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).		30 days
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).		6 months
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)		9 months
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)		24 months
Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])	The is the major Secondary Efficacy Endpoint.	12 months
Ischemia-driven Target Lesion Failure (ID-TLF)	Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR	30 days
Ischemia-driven Target Lesion Failure (ID-TLF)	Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR	6 months
Ischemia-driven Target Lesion Failure (ID-TLF)	This is one of the Secondary Composite Endpoints.	9 months
Ischemia-driven Target Lesion Failure (ID-TLF)	This is one of the Secondary Composite Endpoints.	12 months
Ischemia-driven Target Lesion Failure (ID-TLF)	This is one of the Secondary Composite Endpoints.	24 months
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)		30 days
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)		6 months
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)		9 months
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)		12 months
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)		24 months
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	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)].	30 days
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	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)].	6 months
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	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)].	9 months
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	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)].	12 months
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	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 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI		30 days
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI		6 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI		9 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI		12 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI		24 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)		30 days
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)		6 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)		9 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)		12 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)		24 months
All Revascularization (TLR, TVR, and Non-TVR)		30 Days
All Revascularization (TLR, TVR, and Non-TVR)		6 Months
All Revascularization (TLR, TVR, and Non-TVR)		9 Months
All Revascularization (TLR, TVR, and Non-TVR)		12 months
All Revascularization (TLR, TVR, and Non-TVR)	One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).	24 months
All Death	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.	30 days
All Death	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.	6 months
All Death	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.	9 months
All Death	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.	12 months
All Death	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.	24 months
All Protocol MI (Including Q-wave or Non-Q-wave)	This is one of the secondary safety endpoint.	30 days
All Protocol MI (Including Q-wave or Non-Q-wave)	This is one of the secondary safety endpoint.	6 months
All Protocol MI (Including Q-wave or Non-Q-wave)	This is one of the secondary safety endpoint.	9 months
All Protocol MI (Including Q-wave or Non-Q-wave)	This is one of the secondary safety endpoint.	12 months
All Protocol MI (Including Q-wave or Non-Q-wave)	This is one of the secondary safety endpoint.	24 months
Target Vessel Protocol MI (TV-MI)	This is one of the secondary safety endpoint.	30 days
Target Vessel Protocol MI (TV-MI)	This is one of the secondary safety endpoint.	6 months
Target Vessel Protocol MI (TV-MI)	This is one of the secondary safety endpoint.	9 months
Target Vessel Protocol MI (TV-MI)	This is one of the secondary safety endpoint.	12 months
Target Vessel Protocol MI (TV-MI)	This is one of the secondary safety endpoint.	24 months
Major Bleeding Complications	Secondary safety endpoint.	30 days
Major Bleeding Complications	Secondary safety endpoint.	6 months
Major Bleeding Complications	Secondary safety endpoint.	9 months
Major Bleeding Complications	Secondary safety endpoint.	12 months
Major Bleeding Complications	Secondary safety endpoint.	24 months
Definite / Probable Stent Thrombosis	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.	Acute (<1 day)
Definite / Probable Stent Thrombosis	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.	Subacute (1 - 30 days)
Definite / Probable Stent Thrombosis	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.	Early (0 - 30 days)
Definite / Probable Stent Thrombosis	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.	Late (31 - 365 days)
Definite / Probable Stent Thrombosis	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.	Very late (366 - 772 days)
Definite / Probable Stent Thrombosis	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.	Overall (0 - 772 days)
Patient Compliance With Dual Antiplatelet Therapy (DAPT)		30 days
Patient Compliance With Dual Antiplatelet Therapy (DAPT)		6 months
Patient Compliance With Dual Antiplatelet Therapy (DAPT)		9 months
Patient Compliance With Dual Antiplatelet Therapy (DAPT)		12 months
Patient Compliance With Dual Antiplatelet Therapy (DAPT)		24 months
Acute Device Success	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.	< or = 1 day
Acute Procedure Success	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.	< or = 1 day
Procedure Time	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.	On day 0, during the procedure.
Amount of Contrast Used	Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.	On day 0, during the procedure.
Fluoroscopy Time	This is the procedure related endpoint.	On day 0, during the procedure.
XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire	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.	During the procedure
Follow-up Late Loss	This is one of the Secondary Angiographic Endpoint.	≥13 months.
Follow-up In-stent Minimum Lumen Diameter (MLD)		≥13 months
Follow-up In-stent Percent Diameter Stenosis (DS)		≥13 months
Follow-up In-stent Angiographic Binary Restenosis (ABR)		≥13 months
Follow-up In-segment Minimum Lumen Diameter (MLD)		≥13 months
Follow-up In-segment Percent Diameter Stenosis (DS)		≥13 months
Follow-up In-segment Angiographic Binary Restenosis (ABR)		≥13 months
Percent Diameter Stenosis		pre procedure
Percent Diameter Stenosis (%DS)		post procedure on 0 day
Acute Gain		post procedure on 0 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ID-TVF Rate in Patients With Diabetic Disease	ID-TVF rate in All Diabetes patients.	24 months
ID-TVF Rate in Patients Without Diabetic Disease	ID-TVF rate in Non Diabetes	24 months
ID-TVF Rate in Single Lesion Treated Subgroup	ID-TVF rate in Patients with single lesion treated during the index procedure	24 months
ID-TVF Rate in Dual Lesion Treated Subgroup	ID-TVF rate in Patients with dual lesion treated during the index procedure	24 months
ID-TVF Rate in Single Vessel Treated Subgroup	ID-TVF rate in Patients with single vessels treated during the index procedure.	24 months
ID-TVF Rate in Dual Vessel Treated Subgroup	ID-TVF rate in Patients with dual vessel treated during the index procedure.	24 months
The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.	The composite of ST, all death, and all MI rate in All Diabetes patients.	24 months
The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease	The composite of ST, all death, and all MI rate in Non Diabetes	24 months
The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup	The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure	24 months
The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup	The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure	24 months
The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup	The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.	24 months
The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup	The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.	24 months
ID-TLR Rate in Patients With Diabetic Disease.	Ischemia-driven target lesion revascularization rate in All Diabetes patients.	24 months
ID-TLR Rate in Patients Without Diabetic Disease	Ischemia-driven target lesion revascularization rate in Non Diabetes	24 months
ID-TLR Rate in Single Lesion Treated Subgroup	Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure	24 months
ID-TLR Rate in Dual Lesion Treated Subgroup	Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure	24 months
ID-TLR Rate in Single Vessel Treated Subgroup	Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.	24 months
ID-TLR Rate in Dual Vessel Treated Subgroup	Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.	24 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Gao Runlin, MD, FACC, Fu Wai Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: August 6, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (ESTIMATE): August 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 24, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Stents; Angioplasty; Drug eluting stents
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Ischemia; Thrombosis; Coronary Occlusion; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: 10-387