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

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Artery Disease, In Stent Restenosis

Intervention / Treatment
-----------------
* Device: drug-coated balloon Catheter


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 |