A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety in the treatment of Coronary Small Vessel Disease by drug coated balloon (DCB) Dissolve™ versus drug eluting stent (DES) Resolute™ Integrity.

Official Title
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A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to Resolute™ Integrity in Treatment of Coronary Small Vessel Disease in Chinese Population

Conditions
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Coronary Small Vessel Disease

Intervention / Treatment
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* Device: Cohort A: Dissolve™
* Device: Cohort A: Resolute™ Integrity
* Device: Cohort B: Dissolve™-2.00mm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Related to the patients: Cohort A: 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 (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting) Cohort B: All candidates for Cohort B of this study must meet number 1, 2 of the above criteria and Patients who can receive balloon angioplasty Related to lesion: Cohort A The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia One subject is allowed to have 1 target lesion at most (Two lesions can be treat as one target lesion, if they are in the same vessel, with the distance less than 10mm, with total length ≤ 26mm, and can be intervened by one DCB or DES) Cohort B: All candidates for Cohort B of this study must meet number 6,7 of the above criteria and The reference blood vessel diameter is 2.00mm-2.25mm Exclusion Criteria: Related to patients Patients who had Myocardial Infarction within 1 week before being included Patients with severe congestive heart failure or NYHA grade IV heart failure Left ventricular ejection fraction (LVEF) < 35% Patients who had heart transplantation Patients with severe valvular heart disease 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 with leukopenia (white blood cell count < 3×10^9/L) for more than three days; Patients with low neutrophil counts (ANC < 1000/mm^3) for more than three days; Patients with thrombocytopenia (platelet count < 100,000/mm^3) Patients with renal insufficiency (eGFR < 30mL/min) Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel Patients who are allergic to Paclitaxel or Zotarolimus The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives 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 Patients who have severe calcification of the target lesion, and balloon pre-dilatation could not be performed successfully The target lesions are bifurcation lesion with the diameter of the branch vessel > 2.00mm The target lesions are in-stent restenosis Angiography indicates thrombosis in the target vessel Complicated with lesions in left main (LM) coronary requiring intervention treatment More than 2 non-target lesions need treatment, or the non-target lesion could not be intervened successfully before the target lesion

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: Cohort A: Dissolve™<br> | Device: Cohort A: Dissolve™<br>* Dissolve™ are to be used in the trial<br>* Other names: Paclitaxel coated balloon;|
| Active Comparator: Cohort A: Resolute™ Integrity<br> | Device: Cohort A: Resolute™ Integrity<br>* Resolute™ Integrity are to be used in the trial<br>* Other names: Zotarolimus eluting stent;|
| Experimental: Cohort B: Dissolve™-2.00mm<br>Cohort B is single arm. | Device: Cohort B: Dissolve™-2.00mm<br>* Dissolve™ 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 percent diameter stenosis of the target lesion at 9 months after procedure |  | 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/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final residual stenosis of less than 50% and TIMI 3 blood flow (DCB arm) or less than 30% and TIMI 3 blood flow (DES arm) by visual estimation | From the start of index procedure to the end of index procedure, Day 0 | 
| Lesion success rate of the interventional therapy | Attainment of final residual stenosis of less than 50% and TIMI 3 blood flow (DCB arm) or less than 30% and TIMI 3 blood flow (DES arm) by visual estimation. | From the start of index procedure to the end of index procedure, Day 0 | 
| Clinical success rate of the interventional therapy | Without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat target lesion revascularization (TLR). | 7 days after the procedure | 
| In-device percent diameter stenosis of the target lesion | Restenosis is defined as stenosis > 50% by angiography | 9 months after the procedure | 
| In-device minimal lumen diameter (MLD) |  | 9 months after the procedure | 
| In-segment MLD |  | 9 months after the procedure | 
| In-device late lumen loss (LLL) |  | 9 months after the procedure | 
| In-segment LLL |  | 9 months after the procedure | 
| Binary restenosis rate in lesion section |  | 9 months after the procedure | 
| Target vessel revascularization (TVR) rate |  | 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure | 
| Target lesion failure (TLF) rate |  | 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure | 
| Target lesion revascularization (TLR) rate |  | 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 | 
| Rate of major adverse cardiovascular events | Including death, myocardial infarction (MI), stroke and renal failure | 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure |