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Coronary Artery DiseaseSIBLINT ISRNCT04240444

Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis

A study testing drug-coated balloon Catheter in people with Coronary Artery Disease and In Stent Restenosis, run by B. Braun Medical International Trading Company Ltd. at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, In Stent Restenosis
What is being tested?
drug-coated balloon Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
16 sitesChina
Study dates
10 Oct 2020to 30 Aug 2022
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

  • General criteria
  • Patient ≥18 years of age.
  • Stable angina pectoris or unstable angina pectoris (acute coronary syndrome), prior myocardial infarction or proven asymptomatic myocardial ischemia.
  • Patients are eligible for any type of coronary revascularization.
  • Patients agree to receive angiography follow-up at 9 months after index procedure.
  • Patients agree to receive clinical follow-up at 30 days, 6months, 9 months and 1years after index procedure.
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  • Patients are able to understand the purpose of the study and will comply with the study protocol. The patient is willing to sign informed consent form and understand the risks and benefits described in the informed consent form.
  • lesion related
  • Up to 2 ISR lesions which found by angiography (diameter stenosis ≥70% or ≥ 50% with evidence of ischemia) or functional examination (e.g. FFR<0.8 IVUS<4mm2) will be treated, target segment includes news lesions within 5mm of the stent margin.
  • Up to 2 drug coated balloons (SeQuent® Please Neo or SeQuent® SCB) will be used in the study, with 1 drug coated balloon per lesion.
  • ISR (including bare stents, inert and active drug eluting stents) : Mehran type I, II and III stenosis; The reference vessel diameter of target lesions ranges from 2.5mm to 4.0mm (visual), and the length of each lesion are≤ 34mm (visual).
  • Other de novo lesions needing treatment must be >10mm away from the target lesion.

Who cannot join

  • General criteria
  • Patients with myocardial infarction within 1 week before index procedure.
  • Patients with takayasu arteritis.
  • Patients with severe renal failure, whose Creatinine >2.0 mg/dL (177 mol/L).
  • LVEF<30%.
  • Hb before procedure <10 g/dL.
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  • Patients with Coagulation disorder, platelet count <100,000/mm3.
  • Patients with cardiogenic shock.
  • Patients with diseases who require cytostatic or radiotherapy.
  • Patients who are known to be allergic or contraindicated to aspirin, heparin, clopidogrel, rapamycin, ticagrelor, tirofiban, paclitaxel, or iopromide , or who are allergic to contrast agents and cannot be medically prevented, or who are on cilostazol anticoagulants.
  • Patients with bleeding conditions, or with conditions that increase the risk of bleeding, such as gastrointestinal ulcers, which may be restricted or prohibited from anticoagulant therapy or the use of anticoagulant drugs.
  • Gestational women who were pregnant before receiving treatment with the study device or who planned to be pregnant during the study , and did not use effective contraception until (including) follow-up at 12 months postoperatively; Female patients during lactation.
  • Patients with a life expectancy less than 1 year.
  • Patients who are participating in any other clinical trial.
  • Investigator considered the patients ineligible due to any reasons.
  • lesion related
  • There are more than 3 lesions to be treated (including non-target lesions to be treated), and there are more than 2 lesions to be treated in each coronary artery.
  • There will be more than 5 stents implanted in coronary artery after intervention (including previous and current PCI).
  • After pre-dilatation of target lesion, there will be residual stenosis of target lesion >30% or TIMI blood flow < grade 3, and/ dissections NHLBI grade C,D,E,F.
  • The ISR lesion has been treated in past 6 months.
  • The target lesion is tortuous, severely calcified, angular, and the DCB is expected to be impassable.
  • Target lesion contains thrombosis.
  • Target or non-target lesion(s) located in left main.
  • Patients with previous CABG.
  • Patients with lesions requiring intervention treatment in 3 vessels

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Cangzhou Central Hospital

    Cangzhou, Hebei

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Anhui Provincal Hospital

    Hefei, Anhui

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Meizhou People's Hospital

    Meizhou, Guangdong

  • Nanjing First Hospital

    Nanjing, Jiangsu

  • Ruijin Hospital，Shanghai Jiaotong University，School of medicine

    Shanghai, Shanghai Municipality

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial to Assess the Safety and Efficacy of SeQuent® SCB Balloon in the Treatment of Patients With Coronary Arteries In-stent Restenosis Compared SeQuent® Please Neo

This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects.

Read the detailed description

This is a prospective, multicenter, randomized (1:1) controlled clinical trial, which plans to enroll 260 subjects. The aim of study is to assess the safety and efficacy of SeQuent® SCB in the treatment of in-stent restenosis in coronary arteries.

All eligible subjects with ISR lesion in coronary will be randomly assigned to receive SeQuent® SCB (study group) or receive SeQuent® Please Neo (control group) balloon treatment. All subjects will be scheduled to clinical follow up at 30 days, 6 months, 9 months and 12 months after index procedure and will be scheduled to receive the angiography at 9 months after index procedure. The primary endpoint was segment late luminal loss at 9 months after index procedure.

Being tested
drug-coated balloon Catheter
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.

  • drug-coated balloon CatheterDevice

    All eligible subjects will be assigned randomly to study group or control group, receive PTCA.

Study groups in NCT04240444
Study groupRoleWhat they receive
SeQuent® SCBExperimentalpatients will receive sirolimus (rapamycin)-coated balloon (SeQuent® SCB)
Receives: Device: drug-coated balloon Catheter
SeQuent® Please NeoActive comparatorpatients will receive SeQuent® Please Neo balloon
Receives: Device: drug-coated balloon Catheter

What is being measured

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

  1. In-segment late loss

    In-segment late loss(LLL) is defined as the difference between the MLD immediately after the procedure and the MLD at 9-month follow-up angiography after index procedure. MLDs are measured by QCA.

    Measured: at 9 months after index procedure

Secondary outcomes (5)

  1. The success rate of intervention treatment

    including device success, lesion success and clinical success

    Measured: 1-3 days

  2. Binary restenosis rate of target lesion

    A diameter stenosis of > 50% at the previously treated lesion site, including the originally treated site plus the adjacent vascular segments 5 mm , proximal and 5 mm distal to the site . Percent diameter stenosis was defined as [1(MLD/reference vessel diameter)]100.

    Measured: 9 months after index procedure

  3. Target lesion failure (TLF) rate

    The composite of ischemia-driven revascularization of the target lesion, MI related to the target vessel, or cardiac death related to the target vessel

    Measured: 30 days, 6 months, 9 moths, 12 months after index procedure

  4. PoCE

    a composite of all death, MI and any revascularization

    Measured: 30 days, 6 months, 9 moths, 12 months after index procedure

  5. ARC-defined stent thrombosis

    timing (acute, subacute, late and very late stent thrombosis); relationship (definite, probable and possible stent thrombosis)

    Measured: 30 days, 6 months, 9 moths, 12 months after index procedure

Timeline

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

  1. First posted27 Jan 2020
  2. Study start10 Oct 2020
  3. Primary completion26 Jul 2022
  4. Study completion30 Aug 2022

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
Single blind
Who is masked
Outcomes assessor
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04240444
Sponsor's protocol ID
AAG-G-H-1905
Acronym
SIBLINT ISR
Status last verified
Nov 2023
First submitted
22 Jan 2020
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu H, Li Y, Fu G, An J, Chen S, Zhong Z, Liu B, Qiu C, Ma L, Cong H, Li H, Tong Q, He B, Jin Z, Zhang J, Yuan H, Qiu M, Zhang R, Han Y. Sirolimus- vs Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis: The SIBLINT-ISR Randomized Trial. JACC Cardiovasc Interv. 2025 Apr 28;18(8):963-971. doi: 10.1016/j.jcin.2024.12.024. Epub 2025 Feb 19.

    PubMed 39985511

Questions about this trial

What is this clinical trial studying?

A study testing drug-coated balloon Catheter in people with Coronary Artery Disease and In Stent Restenosis, run by B. Braun Medical International Trading Company Ltd. at 16 sites 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 12 inclusion and 25 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: finished, as of the sponsor's last update on 14 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 16 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

In-segment late loss (time frame: at 9 months after index 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 NCT04240444, which also lists 1 linked publication.

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 14 Nov 2023.

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SIBLINT ISR Clinical Trial NCT04240444 | AzTrials