Coronary Bifurcation Lesions Treated With Biguard Stent System (BIGUARD)
Primary Purpose
Coronary Artery Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biguard sirolimus-eluting bifurcation stent system
Sirolimus-eluting stent system
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Bifurcation lesions, Percutaneous coronary intervention, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Subject must be age≥18 years;
- Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
- Subject is eligible for percutaneous coronary intervention (PCI);
- Subject has symptomatic coronary artery disease or documented silent ischemia;
- Subject is willing to comply with all protocol-required follow-up evaluations;
- Target lesion must be a de novo true bifurcation lesions located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤4.00 mm;
- Target lesion must have visually estimated stenosis ≥50%;
- The lesion length of main branch vessel must measure <40 mm, and the lesion length of side branch vessel must measure <20 mm (by visual estimate);
- Subject with no more than one lesion existing in the same vessel can be chosen, when several bifurcation lesions existing simultaneously;
- Subject with knowledge of trial purpose, informed consents and volition of undergoing coronary angiography and clinical follow-up voluntarily.
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:
- Thrombus, or possible thrombus, present in the target vessel;
- Excessive tortuosity proximal to or within the lesion;
- Excessive angulation proximal to or within the lesion;
- Chronic total occlusion lesion in target vessel not re-canalized;
- severe calcification with unsuccessfully pre-dilated;
- restenosis disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biguard stent system
Sirolimus-eluting stent system
Arm Description
PCI with Biguard sirolimus-eluting bifurcation stent system
PCI with regular sirolimus-eluting stent system
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Proximal Late Loss in millimeter
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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.
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.
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.
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.
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)
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)
Full Information
NCT ID
NCT02597283
First Posted
November 2, 2015
Last Updated
December 5, 2017
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02597283
Brief Title
Coronary Bifurcation Lesions Treated With Biguard Stent System
Acronym
BIGUARD
Official Title
A Prospective, Multi-center, Randomized Trial Comparing Biguard Stent With Regular Sirolimus-eluting Stent System for Patients With Coronary Bifurcation Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Funding issues
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Bifurcation lesions, Percutaneous coronary intervention, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biguard stent system
Arm Type
Experimental
Arm Description
PCI with Biguard sirolimus-eluting bifurcation stent system
Arm Title
Sirolimus-eluting stent system
Arm Type
Active Comparator
Arm Description
PCI with regular sirolimus-eluting stent system
Intervention Type
Device
Intervention Name(s)
Biguard sirolimus-eluting bifurcation stent system
Other Intervention Name(s)
Biguard Stent System
Intervention Description
PCI with Biguard sirolimus-eluting bifurcation stent system
Intervention Type
Device
Intervention Name(s)
Sirolimus-eluting stent system
Other Intervention Name(s)
SES
Intervention Description
PCI with sirolimus-eluting stent system
Primary Outcome Measure Information:
Title
Incidence of Ischemia Driven Target Lesion Failure (ID-TLF)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
In-stent late lumen loss in millimeter
Description
In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)
Time Frame
13 months
Title
Proximal Late Loss in millimeter
Description
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)
Time Frame
13 months
Title
Distal Late Loss in millimeter
Description
Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)
Time Frame
13 months
Title
Incidence of Target Vessel Failure (TVF)
Description
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.
Time Frame
30 days
Title
Incidence of Target Vessel Failure (TVF)
Description
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.
Time Frame
1 year
Title
Incidence of Target Vessel Failure (TVF)
Description
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.
Time Frame
3 year
Title
Incidence of Target Vessel Failure (TVF)
Description
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.
Time Frame
5 year
Title
Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
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.
Time Frame
30 days
Title
Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
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.
Time Frame
1 year
Title
Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
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.
Time Frame
3 year
Title
Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
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.
Time Frame
5 year
Title
Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
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
Time Frame
30 days
Title
Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
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
Time Frame
1 year
Title
Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
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
Time Frame
3 year
Title
Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
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
Time Frame
5 year
Title
Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
Description
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.
Time Frame
30 days
Title
Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
Description
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.
Time Frame
1 year
Title
Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
Description
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.
Time Frame
3 year
Title
Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
Description
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.
Time Frame
5 year
Title
In-stent % Angiographic Binary Restenosis (% ABR) Rate
Description
Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
Time Frame
13 months
Title
In-segment % Angiographic Binary Restenosis (% ABR) Rate
Description
Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
Time Frame
13 months
Other Pre-specified Outcome Measures:
Title
Acute Success: Clinical Procedure
Description
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%.
Time Frame
7 days
Title
Acute Success: Clinical Device
Description
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%.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be age≥18 years;
Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
Subject is eligible for percutaneous coronary intervention (PCI);
Subject has symptomatic coronary artery disease or documented silent ischemia;
Subject is willing to comply with all protocol-required follow-up evaluations;
Target lesion must be a de novo true bifurcation lesions located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤4.00 mm;
Target lesion must have visually estimated stenosis ≥50%;
The lesion length of main branch vessel must measure <40 mm, and the lesion length of side branch vessel must measure <20 mm (by visual estimate);
Subject with no more than one lesion existing in the same vessel can be chosen, when several bifurcation lesions existing simultaneously;
Subject with knowledge of trial purpose, informed consents and volition of undergoing coronary angiography and clinical follow-up voluntarily.
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:
Thrombus, or possible thrombus, present in the target vessel;
Excessive tortuosity proximal to or within the lesion;
Excessive angulation proximal to or within the lesion;
Chronic total occlusion lesion in target vessel not re-canalized;
severe calcification with unsuccessfully pre-dilated;
restenosis disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen, MD
Organizational Affiliation
Director of Cardiology and Cath Lab, Nanjing First Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Coronary Bifurcation Lesions Treated With Biguard Stent System
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