Coronary Artery Disease
Conditions
Brief summary
This study is designed to investigate whether IVUS-guided DK crush stenting technique compared to angiography-guided DK crush after the indexed procedure will lead to lower rates of the composite endpoint of target vessel failure (TVF) at 12 months. The individual components of TVF include cardiac death, target-vessel myocardial infarction (MI), or target vessel revascularization (TVR). Complex bifurcation lesions were defined according to DEFINITION study.
Detailed description
This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 35 international sites. The investigators aim to enroll 556 subjects with complex coronary bifurcation lesions in native coronary arterial segments. All patients with complex coronary bifurcation lesions suitable for DES implantation will undergo 1:1 randomization either to IVUS-guided or angiography-guided DK crush stenting using a randomization schedule blocked by site. All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography before DES implantation. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven TVF, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.
Interventions
PROCEDUREStenting
DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will remain blinded until the final study results are released.
Intervention model description
Patients will undergo 1:1 randomization to either IVUS-guided DKCrush stenting which will be the treatment group or Angio-guided DKCrush stenting which will be the control group based on an online Clinical Research Data Management Platform provided by King Yee,,Beijing CN. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1, 6, and 12 months after the index procedure. Angiographic follow-up is scheduled at 13 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent prior to any study specific procedures; 2. Men and women 18 years and older; 3. Established indication for PCI according to the guidelines of ACC/AHA; 4. Native coronary lesion suitable for drug-eluting stent placement; 5. True bifurcation lesions (Medina 0,1,1/1,1,1), lesions length≤ 68 mm 6. Reference vessel diameter in side branch \> 2.5mm by visual estimation; 7. Complex bifurcation lesions based on the DEFINITION study.
Exclusion criteria
1. Pregnancy and breast feeding mother; 2. Co-morbidity with an estimated life expectancy of \< 50 % at 12 months; 3. Scheduled surgery interrupting antiplatelet medications in the next 6 months; 4. Intolerable to DAPT; 5. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; 6. Unable to provide written informed consent, or fail to follow the protocol; 7. Previous enrolment in coronary intervention device investigation during the study period; 8. Lesion cannot be covered by 2 longest stents; 9. Restenotic bifurcation lesions； 10. Severe calcification requiring rotational atherectomy; 11. Acute myocardial infarction less than 24 hours; 12. Chronic total occlusion which is not recanalized; 13. Simple bifurcation lesions; 14. Renal failure requiring or during dialysis; 15. Hemoglobin \<9g/L 16. Uncontrolled hypertension (systolic blood pressure≥180 mmHg or diastolic blood pressure≥110 mmHg) 17. Severe heart failure (LVEF\<30%) 18. Combined pre- and post-capillary hypertension (mPAP≥25 mmHg, PCWP\>15 mmHg, and PVR\>3.0 WU) 19. Patients with hypertrophic obstructive cardiomyopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of target vessel failure | 12 months after DES implantation | TVF defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of stent thrombosis | 12 months after DES implantation | The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium. |
Countries
China
Outcome results
None listed