IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions

Comparison of Intravascular Ultrasound-guided With Angiography-guided Double Kissing Crush Stenting Technique for Patients With Complex Coronary Bifurcation Lesions: The Prospective, Multi-center, Randomized DKCRUSH VIII Trial

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.

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.

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.