Active, not recruiting
Not applicable
IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions
Condition(s) studied
Coronary Artery Disease
Investigational drug(s) / intervention(s)
Stenting
Stenting: DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Nanjing First Hospital |
Nanjing |
Jiangsu |
|
More Nanjing First Hospital, Nanjing Medical University trials in China
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