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

Coronary Artery Disease Clinical Trial

— SIBLINT ISR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04240444
• Other study ID #: AAG-G-H-1905
• Status: Completed
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: November 2023
• Source: B. Braun Medical International Trading Company Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 30, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• In Stent Restenosis

Intervention

Device:
• drug-coated balloon Catheter
All eligible subjects will be assigned randomly to study group or control group, receive PTCA.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	He Bei
China	The First Bethune Hospital of Jilin University	Changchun	Ji Lin
China	The Second Hospital of Jilin University	Changchun	Ji Lin
China	Daqing Oilfield General Hospital	Daqing	Hei Long Jiang
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhe Jiang
China	Anhui Provincal Hospital	Hefei	An Hui
China	Shandong Provincial Hospital	Jinan	Shan Dong
China	Meizhou People's Hospital	Meizhou	Guang Dong
China	Nanjing First Hospital	Nanjing	Jiang Su
China	Ruijin Hospital,Shanghai Jiaotong University,School of medicine	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	General Hospital of Northern Theater Command	Shenyang	Liao Ning
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Zhengzhou University	ZhengZhou	He Nan

Sponsors (2)

Lead Sponsor	Collaborator
B. Braun Medical International Trading Company Ltd.	CCRF Inc., Beijing, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The success rate of intervention treatment	including device success, lesion success and clinical success	1-3 days
Secondary	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
Secondary	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
Secondary	PoCE	a composite of all death, MI and any revascularization	30 days, 6 months, 9 moths, 12 months after index procedure
Secondary	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