Coronary Artery DiseaseBIGUARDNCT02597283

Coronary Bifurcation Lesions Treated With Biguard Stent System

A study testing Biguard sirolimus-eluting bifurcation stent system and Sirolimus-eluting stent system in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Biguard sirolimus-eluting bifurcation stent system and Sirolimus-eluting stent system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Dec 2015to Dec 2015
Phase: Interventional
Are there results?: None posted in the registry

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

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;

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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.

Who cannot join

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;

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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.

About this study

Official title: A Prospective, Multi-center, Randomized Trial Comparing Biguard Stent With Regular Sirolimus-eluting Stent System for Patients With Coronary Bifurcation Lesions

Read the 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.

Conditions: Coronary Artery Disease
Being tested: Biguard sirolimus-eluting bifurcation stent system, Sirolimus-eluting stent system
Keywords: Bifurcation lesions, Percutaneous coronary intervention, Randomized controlled trial
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biguard sirolimus-eluting bifurcation stent systemDevice
Also called Biguard Stent System
PCI with Biguard sirolimus-eluting bifurcation stent system
Sirolimus-eluting stent systemDevice
Also called SES
PCI with sirolimus-eluting stent system

Study groups in NCT02597283
Study group	Role	What they receive
Biguard stent system	Experimental	PCI with Biguard sirolimus-eluting bifurcation stent system Receives: Device: Biguard sirolimus-eluting bifurcation stent system
Sirolimus-eluting stent system	Active comparator	PCI with regular sirolimus-eluting stent system Receives: Device: Sirolimus-eluting stent system

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (21)

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)
Measured: 13 months
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Dec 2015

First posted5 Nov 2015 (estimated)
Study startDec 2015
Primary completionDec 2015
Study completionDec 2015

Why it stopped: Funding issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02597283
Sponsor's protocol ID: NFHMU20150902
Acronym: BIGUARD
Status last verified: Dec 2017
First submitted: 2 Nov 2015
Last updated: 6 Dec 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Randomized Trial Comparing Biguard Stent With Regular Sirolimus-eluting Stent System for Patients With Coronary Bifurcation Lesions
ClinicalTrials.gov ID: NCT02597283
Acronym / sponsor ID: BIGUARD / NFHMU20150902
Conditions: Coronary Artery Disease
Keywords: Bifurcation lesions, Percutaneous coronary intervention, Randomized controlled trial
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Funding issues
Enrolment: 0 participants (actual)
Lead sponsor: Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
Study start: Dec 2015 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 5 Nov 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Biguard stent system	Experimental	Device: Biguard sirolimus-eluting bifurcation stent systemPCI with Biguard sirolimus-eluting bifurcation stent system
Sirolimus-eluting stent system	Active comparator	Device: Sirolimus-eluting stent systemPCI with regular sirolimus-eluting stent system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (14 listed)

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;

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
Biguard sirolimus-eluting bifurcation stent systemAlso: Biguard Stent SystemPCI with Biguard sirolimus-eluting bifurcation stent system	Device	Biguard stent system
Sirolimus-eluting stent systemAlso: SESPCI with sirolimus-eluting stent system	Device	Sirolimus-eluting stent system

Primary outcome

Incidence of Ischemia Driven Target Lesion Failure (ID-TLF)
Time frame: 12 months
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.

21 secondary outcomes

In-stent late lumen loss in millimeter
Time frame: 13 months
Proximal Late Loss in millimeter
Time frame: 13 months
Distal Late Loss in millimeter
Time frame: 13 months
Incidence of Target Vessel Failure (TVF)
Time frame: 30 days
Incidence of Target Vessel Failure (TVF)
Time frame: 1 year
Incidence of Target Vessel Failure (TVF)
Time frame: 3 year
Incidence of Target Vessel Failure (TVF)
Time frame: 5 year
Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 30 days
Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 1 year
Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 3 year
Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 5 year
Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 30 days
Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 1 year
Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 3 year
Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 5 year
Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 30 days
Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 1 year
Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 3 year
Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 5 year
In-stent % Angiographic Binary Restenosis (% ABR) Rate
Time frame: 13 months
In-segment % Angiographic Binary Restenosis (% ABR) Rate
Time frame: 13 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
Individual participant dataSharing planned: No

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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.

Shao-Liang Chen, MD principal investigator

Director of Cardiology and Cath Lab, Nanjing First Hospital

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 14 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: withdrawn, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of Ischemia Driven Target Lesion Failure (ID-TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02597283.

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 6 Dec 2017.