Coronary Artery Disease Clinical Trial
— DKCRUSH-VIIIOfficial title:
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.
Status | Recruiting |
Enrollment | 556 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
China | Nanjing First Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
Chen SL, Sheiban I, Xu B, Jepson N, Paiboon C, Zhang JJ, Ye F, Sansoto T, Kwan TW, Lee M, Han YL, Lv SZ, Wen SY, Zhang Q, Wang HC, Jiang TM, Wang Y, Chen LL, Tian NL, Cao F, Qiu CG, Zhang YJ, Leon MB. Impact of the complexity of bifurcation lesions treate — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of target vessel failure | TVF defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR. | 12 months after DES implantation | |
Secondary | Rate of stent thrombosis | The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium. | 12 months after DES implantation |
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