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

NCT ID: NCT04240444

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-10
• Study Completion Date: 2022-08-30

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.

Conditions

Coronary Artery Disease; In Stent Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SeQuent® SCB

patients will receive sirolimus (rapamycin)-coated balloon (SeQuent® SCB)

Group Type: EXPERIMENTAL

drug-coated balloon Catheter

Intervention Type: DEVICE

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

SeQuent® Please Neo

patients will receive SeQuent® Please Neo balloon

Group Type: ACTIVE_COMPARATOR

drug-coated balloon Catheter

Intervention Type: DEVICE

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

Interventions

drug-coated balloon Catheter

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CCRF Inc., Beijing, China

INDUSTRY

Sponsor Role: collaborator

B. Braun Medical International Trading Company Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaling Han, academician

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of Northern Theater Command

Locations

Anhui Provincal Hospital

Hefei, Anhui, China

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Nanjing First Hospital

Nanjing, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

The Second Hospital of Jilin University

Changchun, Jilin, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Shandong Provincial Hospital

Jinan, Shandong, China

Ruijin Hospital，Shanghai Jiaotong University，School of medicine

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39985511 (View on PubMed)

Other Identifiers

AAG-G-H-1905

Identifier Type: -

Identifier Source: org_study_id