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Coronary Bifurcation LesionsNCT04899583

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

A study testing Sirolimus Coated Balloon Catheter and a Paclitaxel Coated Balloon Catheter in people with Coronary Bifurcation Lesions, run by Acotec Scientific Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Bifurcation Lesions
What is being tested?
Sirolimus Coated Balloon Catheter and a Paclitaxel Coated Balloon Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 siteChina
Study dates
10 Nov 2021to 1 Nov 2025
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 34Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Lu Hao contact

021-64041990

lu.hao.@zs-hospital.sh.cn

China1 site, 1 recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality

    Ge Junbo, MD, 021-64041990, Ge.junbo@zs_hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Sirolimus Coated Balloon Catheter, a Paclitaxel Coated Balloon Catheter

What participants receive

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

  • Sirolimus Coated Balloon CatheterDevice

    a Sirolimus Coated Balloon Catheter designed and produced by Acotec

  • a Paclitaxel Coated Balloon CatheterDevice

    a Paclitaxel Coated Balloon Catheter(trade name:Bingo)

Study groups in NCT04899583
Study groupRoleWhat they receive
Treatment GroupExperimentala Sirolimus Coated Balloon
Receives: Device: Sirolimus Coated Balloon Catheter
Control GroupActive comparatora Paclitaxel Coated Balloon Catheter
Receives: Device: a Paclitaxel Coated Balloon Catheter

What is being measured

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

  1. Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure.

    Defined as (1-minimum lumen diameter of target lesion/reference vessel diameter)*100% at 9 months post procedure.

    Measured: 9 months post procedure

Secondary outcomes (9)

  1. Rate of device success

    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.

    Measured: Immediately after procedure

  2. Rate of lesion success

    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.

    Measured: Immediately after procedure

  3. Rate of procedure success

    Defined as the rate of achieving lesion success without MACE (composite of cardiac death, MI and TLR events) .

    Measured: Immediately after procedure

  4. Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE）

    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.

    Measured: 30 days, 6 months, 9 months, 12 months post procedure

  5. Rate of patient-related composite endpoints (PoCE）

    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.

    Measured: 30 days, 6 months, 9 months, 12 months post procedure

  6. Diameter stenosis rate

    Defined as the rate of restenosis (>50% diameter stenosis) of main vessel after 9 months at 9 months post procedure.

    Measured: 9 months post procedure

  7. Late lumen loss (LLL)

    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.

    Measured: 9 months post procedure

  8. Angiographic binary restenosis (ABR) rate

    Defined as the percentage rate of binary restenosis determined by angiographic at 9 months post procedure.

    Measured: 9 months post procedure

  9. Rate of composite safety endpoint

    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.

    Measured: 12 months post procedure

Timeline

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

  1. First posted24 May 2021
  2. Study start10 Nov 2021
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion1 Nov 2025 (estimated)

Resources

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
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04899583
Sponsor's protocol ID
ACOART SCB BIF
Status last verified
May 2023
First submitted
17 May 2021
Last updated
29 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sirolimus Coated Balloon Catheter and a Paclitaxel Coated Balloon Catheter in people with Coronary Bifurcation Lesions, run by Acotec Scientific Co., Ltd at 1 site in China.

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 4 inclusion and 34 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lu Hao (021-64041990, lu.hao.@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure. (time frame: 9 months post procedure). 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 NCT04899583.

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 29 Nov 2023.

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