Coronary OcclusionPhase 4NCT01178268
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
A Phase 4 study testing XIENCE V EECSS and CYPHER SELECT PLUS SECSS in people with Coronary Occlusion and Thrombosis (Stent Thrombosis), run by Abbott Medical Devices at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Occlusion, Thrombosis (Stent Thrombosis), Vascular Disease
- What is being tested?
- XIENCE V EECSS and CYPHER SELECT PLUS SECSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2010to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fu Wai Hospital
Beijing, 100037
Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.
Shanghai, 200122
About this study
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.
Read the 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
- Conditions
- Coronary Occlusion, Thrombosis (Stent Thrombosis), Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- Being tested
- XIENCE V EECSS, CYPHER SELECT PLUS SECSS
- Keywords
- Drug eluting stents, Stents, Angioplasty
- Medical subject headings
- Coronary Occlusion, Thrombosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE V EECSSDevice
Patients who will receive this stent.
CYPHER SELECT PLUS SECSSDevice
Patients who will receive this stent.
| Study group | Role | What they receive |
|---|---|---|
| XIENCE V EECSS | Active comparator | Patients who will receive this stent. Receives: Device: XIENCE V EECSS |
| CYPHER SELECT PLUS SECSS | Active comparator | Patients who will receive this stent. Receives: Device: CYPHER SELECT PLUS SECSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: >=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).
Measured: 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).
Measured: 12 months
Secondary outcomes (86)
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])
Measured: 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]).
Measured: 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])
Measured: 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])
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 12 months
Ischemia-driven Target Lesion Failure (ID-TLF)
Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Measured: 30 days
Ischemia-driven Target Lesion Failure (ID-TLF)
Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Measured: 6 months
Ischemia-driven Target Lesion Failure (ID-TLF)
This is one of the Secondary Composite Endpoints.
Measured: 9 months
Ischemia-driven Target Lesion Failure (ID-TLF)
This is one of the Secondary Composite Endpoints.
Measured: 12 months
Ischemia-driven Target Lesion Failure (ID-TLF)
This is one of the Secondary Composite Endpoints.
Measured: 24 months
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Measured: 30 days
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Measured: 6 months
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Measured: 9 months
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Measured: 12 months
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Measured: 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)].
Measured: 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)].
Measured: 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)].
Measured: 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)].
Measured: 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)].
Measured: 24 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Measured: 30 days
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Measured: 6 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Measured: 9 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Measured: 12 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Measured: 24 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Measured: 30 days
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Measured: 6 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Measured: 9 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Measured: 12 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Measured: 24 months
All Revascularization (TLR, TVR, and Non-TVR)
Measured: 30 Days
All Revascularization (TLR, TVR, and Non-TVR)
Measured: 6 Months
All Revascularization (TLR, TVR, and Non-TVR)
Measured: 9 Months
All Revascularization (TLR, TVR, and Non-TVR)
Measured: 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).
Measured: 24 months
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Measured: 30 days
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Measured: 6 months
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Measured: 9 months
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Measured: 12 months
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Measured: 24 months
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Measured: 30 days
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Measured: 6 months
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Measured: 9 months
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Measured: 12 months
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Measured: 24 months
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Measured: 30 days
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Measured: 6 months
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Measured: 9 months
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Measured: 12 months
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Measured: 24 months
Major Bleeding Complications
Secondary safety endpoint.
Measured: 30 days
Major Bleeding Complications
Secondary safety endpoint.
Measured: 6 months
Major Bleeding Complications
Secondary safety endpoint.
Measured: 9 months
Major Bleeding Complications
Secondary safety endpoint.
Measured: 12 months
Major Bleeding Complications
Secondary safety endpoint.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Overall (0 - 772 days)
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Measured: 30 days
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Measured: 6 months
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Measured: 9 months
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Measured: 12 months
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Measured: 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.
Measured: < 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.
Measured: < 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.
Measured: 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.
Measured: On day 0, during the procedure.
Fluoroscopy Time
This is the procedure related endpoint.
Measured: 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.
Measured: During the procedure
Follow-up Late Loss
This is one of the Secondary Angiographic Endpoint.
Measured: ≥13 months.
Follow-up In-stent Minimum Lumen Diameter (MLD)
Measured: ≥13 months
Follow-up In-stent Percent Diameter Stenosis (DS)
Measured: ≥13 months
Follow-up In-stent Angiographic Binary Restenosis (ABR)
Measured: ≥13 months
Follow-up In-segment Minimum Lumen Diameter (MLD)
Measured: ≥13 months
Follow-up In-segment Percent Diameter Stenosis (DS)
Measured: ≥13 months
Follow-up In-segment Angiographic Binary Restenosis (ABR)
Measured: ≥13 months
Percent Diameter Stenosis
Measured: pre procedure
Percent Diameter Stenosis (%DS)
Measured: post procedure on 0 day
Acute Gain
Measured: post procedure on 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary OcclusionStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gao Runlin, MD, FACC, Principal investigator, Fu Wai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178268
- Sponsor's protocol ID
- 10-387
- Status last verified
- Jul 2016
- First submitted
- 6 Aug 2010
- Last updated
- 24 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT01178268
- Acronym / sponsor ID
- 10-387
- Conditions
- Coronary Occlusion, Thrombosis (Stent Thrombosis), Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- Keywords
- Drug eluting stents, Stents, Angioplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Posted 24 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XIENCE V EECSS | Active comparator | Device: XIENCE V EECSSPatients who will receive this stent. |
| CYPHER SELECT PLUS SECSS | Active comparator | Device: CYPHER SELECT PLUS SECSSPatients who will receive this stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- General Inclusion Criteria
- 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,
Key exclusion criteria (21 listed)
- General Exclusion Criteria
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XIENCE V EECSSPatients who will receive this stent. | Device | XIENCE V EECSS |
| CYPHER SELECT PLUS SECSSPatients who will receive this stent. | Device | CYPHER SELECT PLUS SECSS |
Primary outcome
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)
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).
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).
86 secondary outcomes
Ischemia-driven Target Vessel Failure (ID-TVF)
Time frame: 30 days
Ischemia-driven Target Vessel Failure (ID-TVF)
Time frame: 6 months
Ischemia-driven Target Vessel Failure (ID-TVF)
Time frame: 9 months
Ischemia-driven Target Vessel Failure (ID-TVF)
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 24 months
Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])
Time frame: 12 months
Ischemia-driven Target Lesion Failure (ID-TLF)
Time frame: 30 days
Ischemia-driven Target Lesion Failure (ID-TLF)
Time frame: 6 months
Ischemia-driven Target Lesion Failure (ID-TLF)
Time frame: 9 months
Ischemia-driven Target Lesion Failure (ID-TLF)
Time frame: 12 months
Ischemia-driven Target Lesion Failure (ID-TLF)
Time frame: 24 months
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
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
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
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
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
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Time frame: 30 days
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Time frame: 6 months
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Time frame: 9 months
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Time frame: 12 months
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Time frame: 24 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 30 days
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 6 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 9 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 12 months
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 24 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 30 days
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 6 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 9 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 12 months
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 24 months
All Revascularization (TLR, TVR, and Non-TVR)
Time frame: 30 Days
All Revascularization (TLR, TVR, and Non-TVR)
Time frame: 6 Months
All Revascularization (TLR, TVR, and Non-TVR)
Time frame: 9 Months
All Revascularization (TLR, TVR, and Non-TVR)
Time frame: 12 months
All Revascularization (TLR, TVR, and Non-TVR)
Time frame: 24 months
All Death
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gao Runlin, MD, FACC principal investigator
Fu Wai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XIENCE V EECSS and CYPHER SELECT PLUS SECSS in people with Coronary Occlusion and Thrombosis (Stent Thrombosis), run by Abbott Medical Devices at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent Late Loss (LL) (time frame: >=13 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.