Coronary Small Vessel Disease
Conditions
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.
Interventions
DEVICECohort A: Dissolve™
Dissolve™ are to be used in the trial
DEVICECohort A: Resolute™ Integrity
Resolute™ Integrity are to be used in the trial
DEVICECohort B: Dissolve™-2.00mm
Dissolve™ are to be used in the trial
Sponsors
Core Medical (Beijing) Co., Ltd.
DK Medical Technology (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Related to the patients: Cohort A: 1. 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 2. Patients with stable angina, unstable angina, old myocardial infarction (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia 3. 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 4. Patients who can receive balloon angioplasty Related to lesion: Cohort A 5. The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm 6. Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia 7. 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 8. The reference blood vessel diameter is 2.00mm-2.25mm
Exclusion criteria
Related to patients 1. Patients who had Myocardial Infarction within 1 week before being included 2. Patients with severe congestive heart failure or NYHA grade IV heart failure 3. Left ventricular ejection fraction (LVEF) \< 35% 4. Patients who had heart transplantation 5. Patients with severe valvular heart disease 6. 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 7. 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) 8. Patients with renal insufficiency (eGFR \< 30mL/min) 9. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel 10. Patients who are allergic to Paclitaxel or Zotarolimus 11. The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months 12. Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives 13. The patients are participating in any other clinical trials before reaching the primary endpoints 14. Patients who are unsuitable for the study according to the investigator due to other reasons Related to the Lesion: 15. Patients with total occlusion at the target lesion 16. Patients who have severe calcification of the target lesion, and balloon pre-dilatation could not be performed successfully 17. The target lesions are bifurcation lesion with the diameter of the branch vessel \> 2.00mm 18. The target lesions are in-stent restenosis 19. Angiography indicates thrombosis in the target vessel 20. Complicated with lesions in left main (LM) coronary requiring intervention treatment 21. More than 2 non-target lesions need treatment, or the non-target lesion could not be intervened successfully before the target lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment percent diameter stenosis of the target lesion at 9 months after procedure | 9 months after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 percent diameter stenosis of the target lesion | 9 months after the procedure | Restenosis is defined as stenosis \> 50% by angiography |
| 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 | — |
| 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 |
| 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 | 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-segment LLL | 9 months after the procedure | — |
Countries
China
Outcome results
None listed