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| Name | Class |
|---|---|
| Core Medical (Beijing) Co., Ltd. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Dissolve™ | Experimental |
| |
| Cohort A: Resolute™ Integrity | Active Comparator |
| |
| Cohort B: Dissolve™-2.00mm | Experimental | Cohort B is single arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort A: Dissolve™ | Device | Dissolve™ are to be used in the trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-segment percent diameter stenosis of the target lesion at 9 months after procedure | 9 months after the procedure |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Shubin Qiao | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | China | ||||
| Beijing Friendship Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37995506 | Derived | Liu S, Zhou Y, Shen Z, Chen H, Qiu C, Fu G, Li H, Yu Z, Zeng Q, Li Z, Li W, Qiao S; Dissolve SVD investigators. Comparison of Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Small Vessel Disease (from the Dissolve SVD Randomized Trial). Am J Cardiol. 2024 Jan 15;211:29-39. doi: 10.1016/j.amjcard.2023.05.057. Epub 2023 Nov 22. |
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| Cohort A: Resolute™ Integrity | Device | Resolute™ Integrity are to be used in the trial |
|
|
| Cohort B: Dissolve™-2.00mm | Device | Dissolve™ are to be used in the trial |
|
| 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 |
| Beijing |
| China |
| Beijing Hospital | Beijing | China |
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | China |
| Peking Union Medical College Hospital | Beijing | China |
| Peking University People's Hospital, Capital Medical University | Beijing | China |
| Xiangya Hospital of Central South University | Changsha | China |
| West China Hospital, Sichuan University | Chengdu | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | China |
| The Second Affiliated Hospital of Dalian Medical University | Dalian | China |
| General Hospital of Daqing Oil Field | Daqing | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of medicine | Hangzhou | China |
| Union Hospital, Tongji Medical College Huazhong University of Science and Technology | Wuhan | China |
| General Hospital of Ningxia Medical University | Yinchuan | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |