Coronary Bifurcation Lesions Treated With Biguard Stent System (BIGUARD)

December 5, 2017 updated by: Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    1. Thrombus, or possible thrombus, present in the target vessel;
    2. Excessive tortuosity proximal to or within the lesion;
    3. Excessive angulation proximal to or within the lesion;
    4. Chronic total occlusion lesion in target vessel not re-canalized;
    5. severe calcification with unsuccessfully pre-dilated;
    6. restenosis disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Biguard stent system
PCI with Biguard sirolimus-eluting bifurcation stent system
Device: Biguard sirolimus-eluting bifurcation stent system
PCI with Biguard sirolimus-eluting bifurcation stent system
Other Names:
  • Biguard Stent System
Active Comparator: Sirolimus-eluting stent system
PCI with regular sirolimus-eluting stent system
Device: Sirolimus-eluting stent system
PCI with sirolimus-eluting stent system
Other Names:
  • SES

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-stent late lumen loss in millimeter
Time Frame: 13 months
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
Time Frame: 13 months
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
Time Frame: 13 months
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)
Time Frame: 30 days
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)
Time Frame: 1 year
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)
Time Frame: 3 year
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)
Time Frame: 5 year
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)
Time Frame: 30 days
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)
Time Frame: 1 year
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)
Time Frame: 3 year
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)
Time Frame: 5 year
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)
Time Frame: 30 days
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)
Time Frame: 1 year
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)
Time Frame: 3 year
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)
Time Frame: 5 year
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)
Time Frame: 30 days
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)
Time Frame: 1 year
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)
Time Frame: 3 year
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)
Time Frame: 5 year
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
Time Frame: 13 months
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
Time Frame: 13 months
Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
13 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute Success: Clinical Procedure
Time Frame: 7 days
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
Time Frame: 7 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing First Hospital, Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shao-Liang Chen, MD, Director of Cardiology and Cath Lab, Nanjing First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFHMU20150902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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