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

NCT04240444 | Completed

• 1 other identifier: AAG-G-H-1905
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Coronary Artery Disease; In Stent Restenosis

Outcome Measures

Primary Outcomes (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.

  at 9 months after index procedure

Secondary Outcomes (5)

• The success rate of intervention treatment

  1-3 days

• Binary restenosis rate of target lesion

  9 months after index procedure

• Target lesion failure (TLF) rate

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

• PoCE

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

• ARC-defined stent thrombosis

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

Study Arms (2)

SeQuent® SCB

EXPERIMENTAL

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

Device: drug-coated balloon Catheter

SeQuent® Please Neo

ACTIVE COMPARATOR

patients will receive SeQuent® Please Neo balloon

Device: drug-coated balloon Catheter

Interventions

drug-coated balloon Catheter DEVICE

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

SeQuent® Please Neo; SeQuent® SCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• B. Braun Medical International Trading Company Ltd.: lead
• CCRF Inc., Beijing, China: collaborator

Study Sites (16)

Anhui Provincal Hospital

Hefei, Anhui, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Meizhou People's Hospital

Meizhou, Guangdong, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, China

Location

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, China

Location

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Ruijin Hospital，Shanghai Jiaotong University，School of medicine

Shanghai, Shanghai Municipality, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 39985511 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yaling Han, academician

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: October 10, 2020
• Primary Completion: July 26, 2022
• Study Completion: August 30, 2022
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

CN (16)