Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis (SIBLINT ISR)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; In Stent Restenosis
• Intervention / Treatment: Device: drug-coated balloon Catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • An Hui
    • Hefei, An Hui, China
      • Anhui Provincal Hospital
      • Contact: Likun Ma, Professor
  • Beijing
    • Beijing, Beijing, China
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Zening Jin, Professor
  • Guang Dong
    • Meizhou, Guang Dong, China
      • Meizhou People's Hospital
      • Contact: Zhixiong Zhong, Professor
  • He Bei
    • Cangzhou, He Bei, China
      • Cangzhou Central Hospital
  • He Nan
    • ZhengZhou, He Nan, China
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Chunguang Qiu, Professor
  • Hei Long Jiang
    • Daqing, Hei Long Jiang, China
      • Daqing oilfield general hospital
      • Contact: Hui Li, Professor
  • Ji Lin
    • Changchun, Ji Lin, China
      • The First Bethune Hospital of Jilin University
      • Contact: Qian Tong, Professor
    • Changchun, Ji Lin, China
      • The Second Hospital of Jilin University
      • Contact: Bin Liu, Professor
  • Jiang Su
    • Nanjing, Jiang Su, China
      • Nanjing First Hospital
      • Contact: Shaoliang Chen, Professor
  • Liao Ning
    • Shenyang, Liao Ning, China
      • General Hospital of Northern Theater Command
      • Contact: Yaling Han, academician
  • Shan Dong
    • Jinan, Shan Dong, China
      • Shandong Provincial Hospital
      • Contact: Haitao Yuan, Professor
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Chest Hospital
      • Contact: Ben He, Professor
    • Shanghai, Shanghai, China
      • Ruijin Hospital，Shanghai Jiaotong University，School of medicine
      • Contact: Ruiyan Zhang, Professor
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Cardiovascular Hospital
      • Contact: Jian An, Professor
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Chest Hospital
      • Contact: Hongliang Cong, Professor
  • Zhe Jiang
    • Hangzhou, Zhe Jiang, China
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Contact: Guosheng Fu, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• General criteria

  1. Patient ≥18 years of age.
  2. Stable angina pectoris or unstable angina pectoris (acute coronary syndrome), prior myocardial infarction or proven asymptomatic myocardial ischemia.
  3. Patients are eligible for any type of coronary revascularization.
  4. Patients agree to receive angiography follow-up at 9 months after index procedure.
  5. Patients agree to receive clinical follow-up at 30 days, 6months, 9 months and 1years after index procedure.
  6. 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

  1. 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.
  2. 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.
  3. 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).
  4. Other de novo lesions needing treatment must be >10mm away from the target lesion.

Exclusion Criteria:

• General criteria

  1. Patients with myocardial infarction within 1 week before index procedure.
  2. Patients with takayasu arteritis.
  3. Patients with severe renal failure, whose Creatinine >2.0 mg/dL (177 mol/L).
  4. LVEF<30%.
  5. Hb before procedure <10 g/dL.
  6. Patients with Coagulation disorder, platelet count <100,000/mm3.
  7. Patients with cardiogenic shock.
  8. Patients with diseases who require cytostatic or radiotherapy.
  9. 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.
  10. 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.
  11. 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.
  12. Patients with a life expectancy less than 1 year.
  13. Patients who are participating in any other clinical trial.
  14. Investigator considered the patients ineligible due to any reasons.

• lesion related

  1. 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.
  2. There will be more than 5 stents implanted in coronary artery after intervention (including previous and current PCI).
  3. 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.
  4. The ISR lesion has been treated in past 6 months.
  5. The target lesion is tortuous, severely calcified, angular, and the DCB is expected to be impassable.
  6. Target lesion contains thrombosis.
  7. Target or non-target lesion(s) located in left main.
  8. Patients with previous CABG.
  9. Patients with lesions requiring intervention treatment in 3 vessels

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SeQuent® SCB; patients will receive sirolimus (rapamycin)-coated balloon (SeQuent® SCB)	Device: drug-coated balloon Catheter; All eligible subjects will be assigned randomly to study group or control group, receive PTCA.
Active Comparator: SeQuent® Please Neo; patients will receive SeQuent® Please Neo balloon	Device: drug-coated balloon Catheter; All eligible subjects will be assigned randomly to study group or control group, receive PTCA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 9 months after index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of intervention treatment	including device success, lesion success and clinical success	1-3 days
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.	9 months after index procedure
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	30 days, 6 months, 9 moths, 12 months after index procedure
PoCE	a composite of all death, MI and any revascularization	30 days, 6 months, 9 moths, 12 months after index procedure
ARC-defined stent thrombosis	timing (acute, subacute, late and very late stent thrombosis); relationship (definite, probable and possible stent thrombosis)	30 days, 6 months, 9 moths, 12 months after index procedure

Collaborators and Investigators

• Sponsor: B. Braun Medical International Trading Company Ltd.
• Collaborators: CCRF Inc., Beijing, China
• Investigators: Principal Investigator: Yaling Han, academician, The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Actual): July 26, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: AAG-G-H-1905

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No