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This study is designed to test the hypothesis that the Biguard stent system will lead to fewer target lesion failure compared to regular stent system in patients with coronary bifurcation lesions at one year.
The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of Biguard bifurcation stent system and regular stent system in patients with bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure was around 12% after PCI with regular stent system. And the investigators previous data showed that this event at 12-month after Biguard bifurcation stent system was 4%. Considering the lost to follow-up, it is anticipated that up to 400 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biguard stent system | Experimental | PCI with Biguard sirolimus-eluting bifurcation stent system |
|
| Sirolimus-eluting stent system | Active Comparator | PCI with regular sirolimus-eluting stent system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biguard sirolimus-eluting bifurcation stent system | Device | PCI with Biguard sirolimus-eluting bifurcation stent system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Ischemia Driven Target Lesion Failure (ID-TLF) | The number of participants with adverse events that are related to treatment. Adverse events included 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 and Ischemia-driven target vessel revascularization (TVR) by CABG or PCI. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent late lumen loss in millimeter | In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent) | 13 months |
| Proximal Late Loss in millimeter |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Success: Clinical Procedure | 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%. | 7 days |
| Acute Success: Clinical Device |
Inclusion Criteria:
Exclusion Criteria:
Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI within two weeks;
Subject is on dialysis or has serum creatinine level >3.0 mg/dL;
Subject has known allergy to the study stent system or protocol-required concomitant medications;
Subject has any other serious medical illness that may reduce life expectancy to less than 12 months; Patient with cardiac heart failure (above New York Heart Association (classification) III), or left ventricular ejection fraction (LVEF)< 30%;
Subject with hemorrhagic tendency or history of active peptic ulcers, cerebral hemorrhage, or subarachnoid hemorrhage, cerebral stroke within half a year, as well as patients who have contraindication to anti-platelet agents or anticoagulant treatment;
Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint or intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure;
Subject Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk- Subject has more than 1 lesion that requires treatment during the index procedure;
Target lesion meets any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shao-Liang Chen, MD | Director of Cardiology and Cath Lab, Nanjing First Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Sirolimus-eluting stent system | Device | PCI with sirolimus-eluting stent system |
|
|
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)
| 13 months |
| Distal Late Loss in millimeter | Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement) | 13 months |
| Incidence of Target Vessel Failure (TVF) | The number of participants with adverse events that are related to treatment. Adverse events included 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 and Ischemia-driven target vessel revascularization (TVR) by CABG or PCI. | 30 days |
| Incidence of Target Vessel Failure (TVF) | The number of participants with adverse events that are related to treatment. Adverse events included 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 and Ischemia-driven target vessel revascularization (TVR) by CABG or PCI. | 1 year |
| Incidence of Target Vessel Failure (TVF) | The number of participants with adverse events that are related to treatment. Adverse events included 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 and Ischemia-driven target vessel revascularization (TVR) by CABG or PCI. | 3 year |
| Incidence of Target Vessel Failure (TVF) | The number of participants with adverse events that are related to treatment. Adverse events included 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 and Ischemia-driven target vessel revascularization (TVR) by CABG or PCI. | 5 year |
| Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR) | The number of participants with revascularization at target lesion associated with any of following: functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA), revascularization of a target lesion with angiographic diameter stenosis ≥70% by core laboratory QCA without angina or functional study. | 30 days |
| Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR) | The number of participants with revascularization at target lesion associated with any of following: functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA), revascularization of a target lesion with angiographic diameter stenosis ≥70% by core laboratory QCA without angina or functional study. | 1 year |
| Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR) | The number of participants with revascularization at target lesion associated with any of following: functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA), revascularization of a target lesion with angiographic diameter stenosis ≥70% by core laboratory QCA without angina or functional study. | 3 year |
| Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR) | The number of participants with revascularization at target lesion associated with any of following: functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA), revascularization of a target lesion with angiographic diameter stenosis ≥70% by core laboratory QCA without angina or functional study. | 5 year |
| Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR) | The number of participants with 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 | 30 days |
| Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR) | The number of participants with 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 | 1 year |
| Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR) | The number of participants with 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 | 3 year |
| Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR) | The number of participants with 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 | 5 year |
| Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE) | The number of participants with adverse events that are related to treatment. Adverse events 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. | 30 days |
| Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE) | The number of participants with adverse events that are related to treatment. Adverse events 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. | 1 year |
| Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE) | The number of participants with adverse events that are related to treatment. Adverse events 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. | 3 year |
| Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE) | The number of participants with adverse events that are related to treatment. Adverse events 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. | 5 year |
| In-stent % Angiographic Binary Restenosis (% ABR) Rate | Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA) | 13 months |
| In-segment % Angiographic Binary Restenosis (% ABR) Rate | Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA) | 13 months |
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%.
| 7 days |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |