A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.

Official Title
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A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population

Conditions
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Coronary In-stent Restenosis

Intervention / Treatment
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* Device: Dissolve™
* Device: SeQuent®Please


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Related to the patients: Age ≥18 years old Patients who agree to accept the angiography follow-up visit at 9-month and follow up visits at 1-month, 6-month, 9-month, 1-year, 2-year, 3-year, 4-year and 5-year Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting) Related to lesion: Restenosis after the first stent implant (including bare metal stents, stents with inert coating, and stents with active coating): Type Mehran I, Type II and Type III; the reference blood vessel diameter is 2.5 mm-4.0 mm, length ≤ 26mm Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia The distance between other lesion requires interventional therapy and the target lesion must be > 10mm One subject is allowed to have 2 target lesions at most, and 1 paclitaxel drug balloon for each lesion for dilation Residual stenosis must be ≤ 30% after pre-dilatation, and dissection must be ≤ NHLBI type B Exclusion Criteria: Related to patients Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives Patients with cardiogenic shock The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding, or the patients have a bleeding tendency according to the investigator. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate aspirin or clopidogrel. Patients who are not able to tolerate and comply with dual antiplatelet therapy for at least 3 months after operation Patients who have Myocardial Infarction with thrombus or coronary slow flow symptoms and require immediate intervention Patients who had ST-Elevation Myocardial Infarction within 1 week before being included Patients with severe congestive heart failure or NYHA grade IV heart failure Patients with moderate or severe valvular heart disease Patients who had heart transplantation Patients with renal insufficiency (eGFR < 30mL/min) The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months. The patients are participating in any other clinical trials before reaching the primary endpoints Patients who are unsuitable for the study according to the investigator due to other reasons Related to the Lesion: Patients with total occlusion at the target lesion Lesion which cannot be treated by percutaneous transluminal coronary angioplasty (PTCA) or percutaneous intervention (PCI) Reference vessel diameter < 2.0mm Patients with multiple lesions (≥ 3) requiring percutaneous coronary intervention treatment in the same artery 3-vessel disease that all need to be intervened The diameter of the branch lesions in the target lesion ≥ 2.5mm LM lesions and Ostial lesion within 5mm to the root aorta Non-target lesion was not intervened successfully before target lesions being intervened Related to concomitant therapy: Patients cannot tolerate aspirin and/or clopidogrel and or tricagrelor, patients with the history of neutrocytopenia or thrombocytopenia, or patients with severe hypohepatia and prohibited to take clopidogrel Patients known allergic to paclitaxel Patients known allergic to contrast materials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dissolve™<br> | Device: Dissolve™<br>* Dissolve™ are to be used in the trial<br>|
| Active Comparator: SeQuent®Please<br> | Device: SeQuent®Please<br>* SeQuent®Please are to be used in the trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment Late Lumen Loss | In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the device and 5 mm proximal and 5 mm distal to the device from post-procedure to 9 months by angiography. | From the end of procedure to 9 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success rate of the interventional therapy | Successful delivery and use of the assigned balloon at the intended target lesion and successful withdrawal of the delivery system with attainment of final residual stenosis of less than 30% and TIMI 3 blood flow by visual estimation. | From the start of index procedure to end of index procedure | 
| Lesion success rate of the interventional therapy | Attainment of final residual stenosis of target lesion less than 30% and TIMI 3 blood flow by visual estimation. | From the start of index procedure to end of index procedure | 
| Clinical success rate of the interventional therapy | Achievement of final residual stenosis of less than 30% by visual estimation with successful delivery and use of assigned balloon at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat Target lesion revascularization (TLR). | 7 days after the procedure | 
| Rate of restenosis in the target lesions | Restenosis is defined as stenosis > 30% by angiography | 9 months after the procedure | 
| TLR rate |  | 9 months after the procedure | 
| Target vessel revascularization (TVR) rate |  | 9 months after the procedure | 
| Target lesion failure (TLF) rate |  | 9 months after the procedure | 
| Rate of major adverse cardiovascular events |  | 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure | 
| Rate of all adverse events and severe adverse events |  | 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure |