A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease
- Conditions
- Coronary Small Vessel Disease
- Registration Number
- NCT03376646
- Lead Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
Related to the patients:
Cohort A:
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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
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Patients with stable angina, unstable angina, old myocardial infarction (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia
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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
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Patients who can receive balloon angioplasty
Related to lesion:
Cohort A
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The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm
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Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
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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
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The reference blood vessel diameter is 2.00mm-2.25mm
Related to patients
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Patients who had Myocardial Infarction within 1 week before being included
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Patients with severe congestive heart failure or NYHA grade IV heart failure
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Left ventricular ejection fraction (LVEF) < 35%
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Patients who had heart transplantation
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Patients with severe valvular heart disease
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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
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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)
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Patients with renal insufficiency (eGFR < 30mL/min)
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Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
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Patients who are allergic to Paclitaxel or Zotarolimus
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The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months
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Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
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The patients are participating in any other clinical trials before reaching the primary endpoints
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Patients who are unsuitable for the study according to the investigator due to other reasons
Related to the Lesion:
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Patients with total occlusion at the target lesion
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Patients who have severe calcification of the target lesion, and balloon pre-dilatation could not be performed successfully
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The target lesions are bifurcation lesion with the diameter of the branch vessel > 2.00mm
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The target lesions are in-stent restenosis
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Angiography indicates thrombosis in the target vessel
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Complicated with lesions in left main (LM) coronary requiring intervention treatment
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More than 2 non-target lesions need treatment, or the non-target lesion could not be intervened successfully before the target lesion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method In-segment percent diameter stenosis of the target lesion at 9 months after procedure 9 months after the procedure
- Secondary Outcome Measures
Name Time Method 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 In-segment MLD 9 months after the procedure Lesion success rate of the interventional therapy From the start of index procedure to the end of index procedure, Day 0 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.
In-device late lumen loss (LLL) 9 months 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 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure Including death, myocardial infarction (MI), stroke and renal failure
In-device percent diameter stenosis of the target lesion 9 months after the procedure Restenosis is defined as stenosis \> 50% by angiography
Device success rate of the interventional therapy From the start of index procedure to the end of index procedure, Day 0 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
Clinical success rate of the interventional therapy 7 days after the procedure Without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat target lesion revascularization (TLR).
In-device minimal lumen diameter (MLD) 9 months after the procedure In-segment LLL 9 months 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
Trial Locations
- Locations (15)
The Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
Peking University People's Hospital, Capital Medical University
🇨🇳Beijing, China
Xiangya Hospital of Central South University
🇨🇳Changsha, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, China
Fuwai Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
Beijing Hospital
🇨🇳Beijing, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
General Hospital of Daqing Oil Field
🇨🇳Daqing, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
Union Hospital, Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, China
Sir Run Run Shaw Hospital, Zhejiang University School of medicine
🇨🇳Hangzhou, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China