ACOART SCB BIF: Treatment of Coronary Bifurcation Lesion by Sirolimus Coated Balloon vs Paclitaxel Coated Balloon

November 28, 2023 updated by: Acotec Scientific Co., Ltd

A Prospective, Multicenter, Random Controlled Clinical Trail to Evaluate the Effectiveness and Safety of Sirolimus Coated Balloon Versus a Paclitaxel Coated Balloon in the Treatment of Coronary Bifurcation Lesion

The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon. This trial is designed as prospective, multicenter, randomized and open-label.

Study Overview

Status

Status

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

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.

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

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years old and ≤75 years old
  • Diagnosed as stable or unstable angina pectoris, asymptomatic myocardial ischemia or old myocardial infarction, or recent myocardial infarction in stable stage.
  • Eligible for balloon dilatation or stent implantation.
  • Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed

Exclusion Criteria:

  • AMI occurred within 7 days before operation
  • The subjects had congestive heart failure or the heart function was classified as NYHA/KillipIV.
  • Left ventricular ejection fraction (LVEF) < 35%
  • History of heart transplantation
  • The subjects had severe arrhythmias, such as high-risk ventricular extrasystole and / or ventricular tachycardia.
  • The subjects had stroke, gastrointestinal bleeding or active ulcers, or had a high risk of bleeding in the past 6 months.
  • Active bleeding physique or blood coagulation disorder
  • Known renal insufficiency（eGFR<30ml/min）
  • Contraindicated to anticoagulants or antiplatelet agents
  • Has a history of percutaneous coronary intervention (PCI) within 6 months before enrollment.
  • Has contraindications for coronary artery bypass grafting
  • known to be allergic to aspirin, heparin, contrast agents, paclitaxel and sirolimus
  • Life expectancy less than 12 months, or unable to complete a 12-month follow-up
  • Pregnant or lactating females, or who plan to become pregnant during a follow-up period of 1 year after operation
  • The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.

Angiographic Inclusion Criteria:

  • One target lesion (bifurcation lesion) in the coronary artery is allowed, and if there are coexistent non-bifurcated lesions requiring PCI intervention, only one lesion was accepted at most, and the target lesion should be treated after successful PCI treatment of non-target lesion.
  • Target Lesion located in native coronary artery must be de novo
  • Medina classification should be (1.1.1, 1.0.1, 0.1.1)
  • Main branch of target lesion (%DS is ≥70% or ≥50% with clinical symptoms ) is suitable for stent implantation
  • Target Lesion located in main branch should be covered by DES. Moreover, the residual stenosis ≤ 30%, TIMI flow is 3, no complications and branch vessel opening stenosis ≥ 70%.
  • Reference vessel diameter of the branch is 2.0-4.0mm (by visual)
  • Target lesion length ≤ 36mm (by visual)

Angiographic Exclusion Criteria:

  • Target or non-target lesion located in left main
  • Subjects who have non-target lesions of bifurcation
  • The target lesion is trifurcation or multifurcation lesion.
  • Main branch of target lesion located within 3 mm from the ostium of LAD or LCx or RCA
  • The branch lesion is a diffuse long lesion, which could't covered by one DCB.
  • Main or side branch is occlusive lesion, which TIMI flow is 0.
  • Aneurysm existed in the blood vessel at the target lesion
  • Side branch severely calcified or tortuous
  • The blood pressure was too low to tolerate intracoronary injection of ≥ 100ug nitroglycerin
  • Failure pre-dilatation of the side branch ostium (residual stenosis > 30% ,the blood flow in TIMI is not up to grade 3, or has dissection of type C or above according to NHLBI grade)

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 Assignment
  • Masking: None (Open Label)

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: Treatment Group
a Sirolimus Coated Balloon
Device: Sirolimus Coated Balloon Catheter
a Sirolimus Coated Balloon Catheter designed and produced by Acotec
Active Comparator: Control Group
a Paclitaxel Coated Balloon Catheter
Device: a Paclitaxel Coated Balloon Catheter
a Paclitaxel Coated Balloon Catheter(trade name:Bingo)

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
Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure.
Time Frame: 9 months post procedure
Defined as (1-minimum lumen diameter of target lesion/reference vessel diameter)*100% at 9 months post procedure.
9 months post procedure

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
Rate of device success
Time Frame: Immediately after procedure
Defined as the rate of successful delivery and withdrawal of the delivery catheter, and achieving a final in-lesion residual stenosis less than 30% and TIMI flow grade 3 by using the assigned device only.
Immediately after procedure
Rate of lesion success
Time Frame: Immediately after procedure
Defined as the rate of achieving a final in-lesion residual stenosis < 30% by visual estimate and TIMI flow grade 3 by using any percutaneous method.
Immediately after procedure
Rate of procedure success
Time Frame: Immediately after procedure
Defined as the rate of achieving lesion success without MACE (composite of cardiac death, MI and TLR events) .
Immediately after procedure
Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE）
Time Frame: 30 days, 6 months, 9 months, 12 months post procedure
Defined as a composite rate of cardiac death, target vessel-related MI, or ischemia-driven TLR events at 30 days, 6 months, 9 months and 12 months post procedure.
30 days, 6 months, 9 months, 12 months post procedure
Rate of patient-related composite endpoints (PoCE）
Time Frame: 30 days, 6 months, 9 months, 12 months post procedure
Defined as a composite rate of all cause death, all cause-related MI or TLR events at 30 days, 6 months, 9 months and 12 months post procedure.
30 days, 6 months, 9 months, 12 months post procedure
Diameter stenosis rate
Time Frame: 9 months post procedure
Defined as the rate of restenosis (>50% diameter stenosis) of main vessel after 9 months at 9 months post procedure.
9 months post procedure
Late lumen loss (LLL)
Time Frame: 9 months post procedure
Defined as the difference of minimum lumen diameter (MLD) from post procedure to 9 months follow-up, including late lumen loss of main vessel and side branch.
9 months post procedure
Angiographic binary restenosis (ABR) rate
Time Frame: 9 months post procedure
Defined as the percentage rate of binary restenosis determined by angiographic at 9 months post procedure.
9 months post procedure
Rate of composite safety endpoint
Time Frame: 12 months post procedure
Defined as a composite rate of all-cause death, cardiogenic death, myocardial infarction, target vessel-related myocardial infarction, incidence of thrombotic events (acute, subacute, late) defined by ARC at 12 months post procedure.
12 months post procedure

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.
Acotec Scientific Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Zhongshan Hospital

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: Ge Junbo, Shanghai Zhongshan 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.
November 10, 2021

Primary Completion (Estimated)

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.
November 1, 2024

Study Completion (Estimated)

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.
November 1, 2025

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).
May 17, 2021

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.
May 20, 2021

First Posted (Actual)

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.
May 24, 2021

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.
November 29, 2023

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.
November 28, 2023

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.
May 1, 2023

More Information

Terms related to this study

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.
  • ACOART SCB BIF

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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