Clinical trial NCT04240444: Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
In Stent Restenosis
Lead sponsor: B. Braun Medical International Trading Company Ltd.
Sponsor class: INDUSTRY
Collaborators: name: CCRF Inc., Beijing, China
First posted: 2020-01-27
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-segment late loss
timeFrame: at 9 months after index procedure
Secondary outcomes:
measure: The success rate of intervention treatment
timeFrame: 1-3 days
measure: Binary restenosis rate of target lesion
timeFrame: 9 months after index procedure
measure: Target lesion failure (TLF) rate
timeFrame: 30 days, 6 months, 9 moths, 12 months after index procedure
measure: PoCE
timeFrame: 30 days, 6 months, 9 moths, 12 months after index procedure
measure: ARC-defined stent thrombosis
timeFrame: 30 days, 6 months, 9 moths, 12 months after index procedure
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincal Hospital
state: An Hui
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Meizhou
country: China
facility: Meizhou People's Hospital
state: Guang Dong
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: He Bei
city: ZhengZhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: He Nan
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Hei Long Jiang
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Ji Lin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Ji Lin
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiang Su
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liao Ning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shan Dong
city: Shanghai
country: China
facility: Ruijin Hospital，Shanghai Jiaotong University，School of medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
state: Zhe Jiang
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Yaling Han, academician
role: PRINCIPAL_INVESTIGATOR
References: